Frederick R. Ball

Representative Matters

• Represented a candy manufacturer in consumer class action related to product recall. Obtained early favorable resolution for client.

• Representing Y-mAbs, providing regulatory advise including A&P, contracting, etc.

• Represented Somerset Therapeutics LLC in settling Hatch-Waxman litigation related to 0.7% olopatadine ophthalmic solution in the United States, a generic version of PATADAY® Once-Daily, permitting entry into the market prior to patent expiry.

• Representing Artsana, the 100% shareholder of The Boppy Company, in the CPSC recall of its Infant Lounger; over 3,000,000 newborn loungers were recalled, making it one of the largest CPSC product recalls in recent history.

• Represented capital market company, providing regulatory diligence on multiple ATM offerings as team lead.

• Represented financial services company, providing regulatory diligence on multiple ATM offerings as team lead.

• Represented Patrin Pharma in Hatch-Waxman litigation related to Assertio’s migraine medication, Cambia (Assertio Therapeutics, Inc. et al. v. Patrin Pharma, Inc., Civil Action No. 20-cv-05055 (N.D. Ill.). Achieved a settlement and license agreement related to all asserted patents.

• Represented Windlas Healthcare PVT. Ltd. against Astellas Pharma Inc. in Hatch-Waxman litigation related to Astellas’ overactive bladder treatment Myrbetriq. The matter settled with a license agreement between Astellas and Windlas.

• Represented iAnthus Capital Holdings, Inc. (CSE: IAN; OTCQX: ITHUF) in its acquisition of CBD For Life, a top-ranked producer of innovative CBD-infused wellness, self-care, and beauty products.

• Conducted a twelve state analysis of federal and state regulatory framework pertaining to the distributing, marketing, and selling of hemp and hemp-derived CBD, including CA, VA, MD, NC, PA, OH, KY, IN, WV, OR, WA and NY.

• Represented SVB Leerink LLC, acting as sales agent in a $100 million at the market equity offering of common stock for Cassava Sciences, Inc. (Nasdaq: SAVA), a clinical-stage biotechnology company which works to develop novel solutions for Alzheimer’s disease and other neurodegenerative diseases.

• Represented Roth Capital Partners, LLC, acting as sales agent in a $50 million at the market equity offering of common stock for Ampio Pharmaceuticals, Inc. (NYSEAmerican: AMPE), a development stage pharmaceutical company attempting to develop a treatment for prevalent inflammatory conditions for which there are limited treatment options.

• Represented JonesTrading Institutional Services LLC, acting as sales agent in a $30 million capital on demand offering of common stock for Curis, Inc. (Nasdaq: CRIS), a clinical-stage biotechnology company seeking to develop and commercialize innovative drug candidates for the treatment of human cancers.

• Represented The Benchmark Company LLC, acting as underwriter in a $12.5 million offering of preferred stock for Fortress Biotech, Inc. (Nasdaq: FBIOP), a developer of pharmaceutical and biotechnology products and product candidates.

• Represented B. Riley FBR, Inc., acting as sales agent in a $150 million at the market equity offering of common stock for Novavax, Inc. (Nasdaq: NVAX), a late stage biotechnology company focused on the discovery, development and commercialization of vaccines to prevent serious infectious diseases, including a potential COVID-related vaccine.

• Represented B. Riley FBR, Inc., acting as sales agent in a $4.6 million at the market equity offering of common stock for Hepion Pharmaceuticals, Inc. (NYSE American: HEPA), a developer of targeted therapies for liver disease arising from chronic hepatitis, non-alcoholic steatohepatitis, fibrosis, and liver cancer.

• Represented JMP Securities LLC, acting as sales agent in an $18.9 million at the market equity offering of common stock for Altimmune, Inc. (Nasdaq: ALT), a clinical-stage biopharmaceutical company which develops treatments for liver disease and immune modulating therapies.

• Represented JMP Securities LLC, acting as sales agent in a $25 million at the market equity offering of common stock for iCAD, Inc. (Nasdaq: ICAD), a global medical technology company that provides innovative cancer detection and therapy solutions.

• Represented JMP Securities LLC and Oppenheimer & Co., acting as underwriters in a $25 million public offering of common stock and related warrants for Baudax Bio, Inc. (Nasdaq: BXRX), a pharmaceutical company primarily focused on developing and commercializing innovative products for acute care settings.

• Advised publically traded company related to banking covenants and offering of CBD products.

• Represented Flexpoint Ford, a Chicago-based private equity firm focused on the healthcare and financial services industries, in its investment in YPrime, a global leader of cloud-based eClinical solutions.

• Represent a vertically-integrated operator with licenses in MA, MD, and NH in various aspects of its business, including general corporate, capital raising, and intellectual property.

• Represented underwriter related to At the Market (ATM) offering by a publically traded company considering offering CBD infused cosmetics and beverages.

• Advised a client in the tobacco industry on labeling of CBD products to comply with federal and state law.

• Reviewed advertising and promotional material for multiple companies offering CBD products to assure compliance with federal law (FDA and FTC).

• Drafted a compliance program covering the anti-kickback statute, FCPA, UK Bribery Act, and employee screening for debarment and exclusion for a CSO that provides services to clinical studies sponsors.

• Represented firm client Wockhardt in New Jersey related to Janssen Biotech Inc.’s oncology medication Zytiga. The District Court found the Janssen patent invalid.

• Represented a generic pharmaceutical manufacturer in Inter Partes Review litigation related to a prescription drug resulting in an agreement to settle with a license date prior to expiration of patents.

• Provided regulatory and intellectual property support to the in-house regulatory team of Wockhardt, a pharmaceutical and biotechnology company, for the development of a Risk Evaluation and Mitigation Strategy (“REMS”) for a generic sodium oxybate product that was recently approved by the U.S. Food and Drug Administration (“FDA”).

• Obtained voluntary no-pay dismissals for a pharmaceutical distributor after filing summary judgment motions establishing that our client’s over-the-counter talcum powder was not contaminated with asbestos and that the plaintiffs’ personal injury claims were preempted by the Federal Food, Drug and Cosmetics Act.

• Jazz Pharmaceuticals, Inc. et al. v. Wockhardt Bio AG et al., 2:15-cv-5619 (D.N.J. 2015). Obtained settlement for defendant Wockhardt Bio AG in a patent litigation matter relating to Jazz Pharmaceutical's treatment for narcolepsy, Xyrem.

• Obtained on behalf of Novel Laboratories Inc. a settlement of a patent litigation matter, which will allow Novel to begin marketing its generic form of a medication well prior to the expiration of the patents.

• Represented Wockhardt in Paragraph IV litigation involving Otsuka's oral Abilify. Negotiated a settlement and license agreement permitting entry into the market prior to the expiration of the Orange Book Patents.

• Pfizer Inc., et al. v. Wockhardt, Ltd., et al., 12-CV-817 (SLR) (Consolidated) (D. Del.) Patent infringement action regarding Wockhardt's ANDA to make a generic version of Pfizer's antidepressant product Pristiq®, the active ingredient of which is desvenlafaxine succinate.
• Avanir Pharmaceuticals, Inc., et al. v. Wockhardt, Ltd., et al., 11-CV-704 (Consolidated) (LPS) (D. Del.) Obtained a settlement in a patent infringement action allowing Wockhardt to market a generic version of Avanir’s PBA product Nuedexta®, the active ingredients of which are dextromethorphan hydrobromide and quinidine hydrobromide.

• Obtained a settlement for Wockhardt, a global pharmaceutical and biotechnology company, with Abbott and Alkermes regarding the drug Tricor.

• Obtained a settlement for Wockhardt, a global pharmaceutical and biotechnology company, that resolved Hatch-Waxman litigation initiated by Sepracor Inc. seeking to bar Wockhardt from offering a generic version of the blockbuster insomnia medicine Lunesta. Sepracor agreed to allow Wockhardt entry into the market before the expiration of its Lunesta patents.

• Represented generic pharmaceutical manufacturer Wockhardt in Paragraph IV and Hatch-Waxman litigation, obtaining settlement allowing entry into the market prior to patent expiration.

• Obtained return of $1.6 million worth of alleged contraband seized by the U.S. Drug Enforcement Administration.

• Advised private equity firm in acquisition of dietary supplement manufacturer regarding U.S. and China regulatory issues.

• Represented dietary supplement manufacturer in negotiation of consent decree with FDA following alleged repeated violations of good manufacturing practices.

• Obtained temporary restraining order against state of Washington halting a 6 percent reduction in Medicaid reimbursement to pharmacies.

• Negotiated voluntary surrender of DEA registration on behalf of pharmacy and owner allegedly engaged in significant diversion of controlled substances in violation of federal and state law. In return, DEA agreed not to pursue criminal or civil actions and permitted transfer of controlled substances to another pharmacy.

• Obtained no further action letter from state authorities on behalf of corporation and new management following voluntarily self-reporting of violations of state controlled substances act and statutes and regulations governing out of state wholesalers after internal investigation.

• Represented dietary supplement manufacturer in criminal proceedings related to violations of Food Drug and Cosmetic Act.

• Represented dietary supplement manufacturer before the National Advertising Division of the Better Business Bureau regarding advertising claims.

• Obtained preliminary injunction on behalf of National Association of Chain Drug Stores and National Community Pharmacists Association in litigation against federal Department of Health and Human Services and Centers for Medicare and Medicaid enjoining implementation of reimbursement rule that would have cost pharmacies $8 billion.

• Ikon v. Reeves: obtained temporary restraining order and preliminary injunction enforcing restrictive covenants
• Innotek v. Wright Medical: successful defense of trade secrets arbitration
• Gustafson v. Gonzales: obtained temporary restraining order and permanent injunction enforcing restrictive covenants

• Represented drug wholesaler in criminal and civil investigation regarding importation of unapproved new drugs.

• Represented several mail order pharmacies in DEA, FDA, and DOJ investigations regarding dispensing of controlled substances.

• Prepared and negotiated "voluntary" recalls on behalf of several manufacturers of dietary supplements and generic pharmaceuticals for alleged violations of cGMP.

• Advised numerous wholesalers and manufacturers on registration and pedigree requirements.

• Advised numerous entities on import requirements for registration and APIs.

• Represented compounding pharmacy during criminal, civil, and administrative investigation into dispensing HGH.

• Represented a generic pharmaceutical company in all regulatory matters related to acquisition.

Areas of Practice

• Regulatory Enforcement
• ANDA Litigation
• Commercial Litigation
• White-Collar Defense

Admissions

• Illinois
• Massachusetts
• Supreme Court of the United States
• U.S. Court of Appeals for the Seventh Circuit
• U.S. Court of Appeals for the Eighth Circuit

Education

• Cornell Law School, J.D., 1996

Experience

• Duane Morris LLP
  - Partner, 2005-present
  - Associate, 1999-2004
• DePaul University School of Law
  - Adjunct Professor of Law, 2009-2013
• Holleb & Coff, Chicago, Illinois
  - Associate, 1996-1999
• United States Army, 1985-1993

Professional Activities

• Member, New Hampshire Public Radio Finance Committee, 2024
• Illinois State Bar Association
  
• Food and Drug Law Institute
  - Executive Committee, 2016-2024
  - Treasurer, 2016-2024
  - Board of Directors 2014-2016
  - Finance Committee, 2024-present
    - Board of Editors -- Food and Drug Law Journal, 2022-present

Media Hits

• Interviewed in "MassMEDIC Regulatory Roundup," (Video) March 2023

Selected Publications

• Co-author, "FDA Issues Guidance on Remote Clinical Trial Activities," Duane Morris Alert, October 21, 2024
• Co-author, "FDA Issues Draft Guidance on Predetermined Change Control Plans for Medical Devices," Duane Morris Alert, September 23, 2024
• Co-author, "FDA Finalizes New Rule for Lab-Developed Tests," Duane Morris Alert, May 20, 2024
• Co-author, "FTC Supports Marching In on Patent Rights as a Mechanism to Control Drug Prices," Duane Morris Alert, February 15, 2024
• Co-author, "FDA Warning Letters Explained: An Opportunity, Not a Threat," Duane Morris Alert, November 21, 2023
• Co-author, "New FDA Draft Guidance Documents Stand to Alter the 510(k) Process for Medical Devices," Duane Morris Alert, October 3, 2023
• Co-author, "Introducing Cosmetics Direct – FDA's New Electronic Portal for Cosmetic Facility Registration and Product Listing Under MoCRA," Duane Morris Alert, September 18, 2023
• Co-author, "FDA Issues Second Warning Letter of 2023 Over Potentially Misleading Efficacy Claims Regarding Inhaler," Duane Morris Alert, August 29, 2023
• Co-author, "FDA Issues Draft Guidance on Pre-market Submissions for Patient-Matched Guides to Orthopedic Implants," Duane Morris Alert, August 16, 2023
• Co-author, "Next Phase of MoCRA Rollout: FDA Draft Guidance on Registration and Listing of Cosmetic Product Facilities and Products," Duane Morris Alert, August 8, 2023
• Co-author, "Latest FDA Guidance Includes Minor Procedural Updates to Q-Subs for Medical Devices," Duane Morris Alert, July 10, 2023
• Co-author, "Beauty and Personal Care Products Post-MoCRA Regulatory Compliance Checklist," Lexis Nexis Practical Guidance, June 2023
• Co-author, "CMS Issues Initial Guidance on Medicare Drug Price Negotiation Program," Duane Morris Alert, March 29, 2023
• Co-author, "MoCRA Is Here -- Now What? Unpacking Litigation and Regulatory Risk for Cosmetics Brands Following MoCRA's Enactment," Food and Drug Law Institute, Spring 2023
• Co-author, "FDA Kicks Can on CBD Regulation: CBD Product Manufacturers and Researchers Need to Be Alert for Enforcement," Duane Morris Alert, January 30, 2023
• Co-author, "Congress Overhauls FDA Cosmetics Authority in Year-End Appropriations Bill," Duane Morris Alert, January 4, 2023
• Co-author, "FDA and USPTO Announce Public Listening Session to Promote Greater Access to Medicines," Duane Morris Alert, December 27, 2022
• Co-author, "FDA Issues Final Guidance on Clinical Decision Support Software," Duane Morris Alert, October 21, 2022
• Co-author, "DOJ Announces an Enhanced Approach to Corporate Criminal Enforcement," Duane Morris Alert, October 17, 2022
• Co-author, "DOJ Filing Reawakens Fraud-On-The-FDA Theory Of Liability," Law360, August 19, 2022 
• Co-author, "FDA Issues Guidance on the Background and Evaluation of Therapeutic Equivalence Codes," Duane Morris Alert, August 4, 2022
• Co-author, "FTC Publishes Proposed Changes to Guides Concerning the Use of Endorsements and Testimonials in Advertising," Duane Morris Alert, June 28, 2022
• Co-author, "DOJ Clarifies Position on Fraud-on-the-FDA Theory of False Claims Act Liability," Duane Morris Alert, June 27, 2022
• Co-author, "FDA Issues Guidance on Compounding Animal Drugs from Bulk Drug Substances," Duane Morris Alert, April 20, 2022
• Co-author, "FDA Issues Final Guidance on Initiation of Voluntary Recalls," Duane Morris Alert, March 16, 2022
• Co-author, "District Court of Delaware Rules for Generic Pharma's Use of Skinny Label, but Permits Induced Infringement Suit to Proceed Against Insurer," Duane Morris Alert, February 10, 2022
• Co-author, "Pharmaceutical Research and Manufacturers of America's Revised Code Takes Effect," Duane Morris Alert, January 13, 2022
• Co-author, "FDA Issues Draft Guidance on Content of Premarket Submissions for Device Software Functions," Duane Morris Alert, December 6, 2021
• Co-author, "FDA Issues Final Rule on 'Intended Use'," Duane Morris Alert, September 27, 2021
• Co-author, "Attorney General's Memorandum Allows Prosecution for Noncompliance with Agency Guidance Documents," Duane Morris Alert, September 1, 2021
• Co-author, "Federal Circuit's Rehearing Decision Confirms Induced Infringement Even When Skinny Label Was Used," August 30, 2021
• Co-author, "FDA Issues Final Guidance on Form and Content of Unique Device Identifier Labeling System," Duane Morris Alert, July 26, 2021
• Co-author, "FDA Issues Final Guidance on Post-Approval Chemistry, Manufacturing and Controls Changes to Biologics," Duane Morris Alert, June 28, 2021
• Co-author, "D.C. Circuit Rules That FDA Lacks Authority to Regulate a Product as a Drug When It Also Satisfies Statutory Definition of a Device," Duane Morris Alert, April 26, 2021
• Co-author, "New FDA Guidance Embraces "Remote Interactive Evaluations" but Stops Short of Permitting Virtual 704(a) Inspections," Duane Morris Alert, April 19, 2021
• Co-author, "FDA's Additional Draft Guidance on Biosimilarity and Interchangeability to Seek Comments and Suggestions by January 19, 2021," Duane Morris Alert, December 11, 2020
• Co-author, "Guidance for Formal Meetings Between FDA and ANDA Applicants of Complex Products Under GDUFA II," Duane Morris Alert, December 3, 2020
• Co-author, "HHS OIG Issues Rare Special Fraud Alert Addressing Speaker Programs," Duane Morris Alert, November 30, 2020
• Co-author, "Federal Circuit Holds That, for Venue Purposes, Patent Infringement Occurs Only in Districts Where Actions Related to ANDA Submissions Occur," Duane Morris Alert, November 18, 2020
• Co-author, "Could COVID-19 Data Help Medical Device Manufacturers Accelerate the FDA Approval Process?" Wharton Health Care Management Alumni Association, November 9, 2020
• Co-author, "Federal Circuit Finds Induced Infringement of Drug Patent, Even When Skinny Label Was Used," Duane Morris Alert, October 30, 2020
• Co-author, "Take a Number: FDA Releases Imported Drug Guidance on How to Acquire a National Drug Code," Duane Morris Alert, October 8, 2020
• Co-author, "FDA Clarifies Types of Evidence It Will Consider When Determining a Medical Product's 'Intended Use'," Duane Morris Alert, October 6, 2020
• Co-author, "New MAPP Explains Process for Changing Ownership of Generic Drug Applications," Duane Morris Alert, September 8, 2020
• Co-author, "New Guidance Reveals FDA's Thinking on Imposition of Civil Monetary Penalties for Violations of Clinical Trial Reporting Requirements," Duane Morris Alert, August 27, 2020
• Co-author, "FDA Clarifies Policy on Scope of Review of Multiple-Function Device Products," Duane Morris Alert, August 6, 2020
• Co-author, "FDA Issues Guidance on Procedures for Device Establishment Inspections," Duane Morris Alert, July 8, 2020
• Co-author, "FDA Issues Temporary Policy on Distribution of Drug Samples During COVID-19," Duane Morris Alert, June 18, 2020
• Co-author, "New FDA Compliance Program Details FDA Expectations for Inspections of CDER- or CDRH-Led Combination Product Manufacturers," Duane Morris Alert, June 12, 2020
• Co-author, "FDA Provides Two New Guidances for Investigational New Drug Applications and Clinical Trial Expectations for Drugs and Biological Products Proposed for Use Against COVID-19," Duane Morris Alert, June 1, 2020
• Co-author, "CDC Provides Guidance on COVID-19 Antibody Testing," Duane Morris Alert, May 29, 2020
• Co-author, "FDA Takes Steps to Enhance Availability of Safe and Effective Face Masks," Duane Morris Alert, April 22, 2020
• Co-author, "CARES Act Expands Immunity Protections for Covered Countermeasures and Healthcare Volunteers," Duane Morris Alert, April 13, 2020
• Co-author, "CARES Act Package Ushers in Changes to OTC Drug Review Process," Duane Morris Alert, April 13, 2020
• Co-author, "FDA Unveils Program to Expedite Coronavirus Treatments," Duane Morris Alert, April 1, 2020
• Co-author, "FDA Guidance Aims to Accelerate Availability of COVID-19 Tests," Duane Morris Alerts, March 18, 2020
• Co-author, "FDA's Report on CBD Reaffirms Status Quo," Duane Morris Alert, March 13, 2020
• Co-author, "FDA Postpones Foreign Inspections Through April in Response to COVID-19," Duane Morris Alert, March 12, 2020
• Co-author, "A Cannabidiol Catalyst? Recent Events Increase Pressure on FDA to Regulate CBD," FDLI Update, Spring 2020
• Co-author, "FDA Revises Policies and Procedures for Prioritization of ANDAs," Duane Morris Alert, February 6, 2020
• Co-author, "FDA Provides Insight on Research and Drug Approval for Cannabis Products," Duane Morris Alert, January 24, 2020
• Co-author, "Federal Minimum Age for Purchase of Tobacco Products Including E-Cigarettes Raised from 18 to 21," Duane Morris Alert, December 24, 2019
• Quoted in "'Supplement' On CBD Product Label A Bullseye For US Litigants, Says Attorney," The Rose Sheet, December 13, 2019
• Co-author, "With a Flurry of Warning Letters and a Consumer Update, FDA Signals Commitment to CBD Enforcement Policy," Duane Morris Alert, December 2, 2019
• Co-author, "FDA's Bark May Be Worse Than Its Bite: Revised Guidance Permits Certain Compounding of Animal Drugs from Bulk Drug Substances," Duane Morris Alert, November 25, 2019
• Co-author, "U.S. Senators Urge Changes to Testing Requirements Under USDA Interim Final Rule for Hemp Program," Duane Morris Alert, November 22, 2019

• Quoted in “Regulatory Uncertainty Hangs Over Production of Industrial Hemp,” Agri-Pulse, November 20, 2019

• Co-author, "In a Regulatory 'One-Two,' FDA Modifies Terms of Oversight Concerning Homeopathic Drugs," Duane Morris Alert, October 31, 2019
• Co-author, "Federal Agencies Issue Draft Guidance for Drug Master Files for First Time in 30 Years," Duane Morris Alert, October 22, 2019
• Co-author, "Discovery Ruling in District of Minnesota May Have Far-Reaching Implications for FCA Defendants," Duane Morris Alert, October 8, 2019
• Co-author, "FDA's New Medical Device Rules Speed Up Review Process," Law360, October 2, 2019

• Co-author, "DEA Announcement on Improving Access to Marijuana Research," Duane Morris Alert, September 3, 2019

• Co-author, "OTC Personal Products Manufacturer Cited by FDA for Various Regulatory Violations," Duane Morris Alert, August 27, 2019

• Co-author, "CMS Issues Proposed Regulations to Expand Open Payments System Reporting," Duane Morris Alert, August 26, 2019

• Co-author, "FDA Releases Guidance on REMS Modifications and Revisions," Duane Morris Alert, August 9, 2019

• Co-author, "BYOD and eCOA: A Match Made in Heaven?" FDLI Update, July/August, 2019

• Quoted, "FDA Warns Curaleaf to Stop Marketing CBD with Unfounded Claims, Boston Globe, July 23, 2019

• Co-author, "FDA Comments on the Public Hearing on Products Containing Cannabis and Cannabis-Derived Compounds and Extends Comment Period," Duane Morris Alert, June 24, 2019

• Co-author, "How Will FDA Bring Order to the Wild West of Cannabis Regulations?" Food and Drug Law Institute, June 10, 2019

• Co-author, "FDA Releases Draft Guidance on Voluntary Recalls," Duane Morris Alert, May 13, 2018

• Co-author, "FDA's Next Steps for Cannabis Products," Duane Morris Alert, April 4, 2019

• Co-author, "AdvaMed's Updated Code of Ethics," Duane Morris Alert, February 12, 2019

• Co-author, "Study Sponsors Take Heed: FDA Plans Changes to Expanded Access Program," Duane Morris Alert, Febuary 7, 2019

• Co-author, "The 2018 Farm Bill Preserves FDA Right to Regulate Cannabis Products," Duane Morris Alert, February 4, 2019

• Co-author, "FDA Issues Final Guidance on Data Integrity and Compliance with CGMP," Duane Morris Alert, January 14, 2019

• Co-author, "DOJ Implements Granston Memo: Motions to Dismiss Filed in 11 False Claims Act Cases," Duane Morris Alert, January 3, 2019

• Co-author, "FDA Announces New UDI Compliance Deadlines via Another Guidance Document," Duane Morris Alert, December 27, 2018

• Co-author, "FDA Provides Guidance on Uncertainty Considerations in Benefit-Risk Determinations for Medical Device Premarket Approvals," Duane Morris Alert, November 27, 2018

• Co-author, "Redraft of 510(k) Third Party Review Program," Duane Morris Alert, November 8, 2018

• Co-author, "CDER's New MAPP on Risk-Based Site Selection Model for Routine Inspections," Duane Morris Alert, November 7, 2018

• Co-author, "SUPPORT Act Expands Sunshine Act Disclosure Requirements," Duane Morris Alert, October 25, 2018

• Co-author, "FDA Unveils New Quality in 510(k) 'Quik' Review Program Pilot," Duane Morris Alert, October 22, 2018

• Co-author, "Case Study: Jazz Pharmaceuticals v. Anmeal Pharmaceuticals," FDLI Update, October/November 2018

• Co-author, "FDA Releases Revised Draft Memorandum of Understanding for Human Drug Compounding," Duane Morris Alert, October 1, 2018

• Co-author, "FDA Publishes Draft Guidance Seeking Innovative Approaches for Nonprescription Drug Product Labeling and Additional Conditions for Use," Duane Morris Alert, August 8, 2018

• Co-author, "FDA Publishes Draft Guidance for Field Alert Report Submission," Duane Morris Alert, August 7, 2018

• Co-author, "Federal Circuit Confirms PTAB Decision Invalidating Certain Claims of Xyrem Patents," Duane Morris Alert, July 23, 2018

• Co-author, "FDA Proposes to Amend Product Jurisdiction Regulations Without Any Significant Substantive Changes," Duane Morris Alert, June 12, 2018

• Co-author, "Formal Meetings Between FDA and ANDA Applicants of Complex Products Under GDUFA," Duane Morris Alert, November 21, 2017

• Contributor, Duane Morris White Collar Criminal Law Blog
• Co-author, "FDA Outlines Its Operation for Facility Evaluation," Duane Morris Alert, September 14, 2017
• Co-author, "FDA Increases Priority Review Opportunities for Drug Products with Limited Competition," Duane Morris Alert, July 18, 2017
• Co-author, "FDA Issues Draft Guidance on Pre-Submission Facility Correspondence - A Way to Reduce FDA Action Times for Priority ANDAs," Duane Morris Alert, July 14, 2017
• Co-author, "FDA's Draft Guidance for Industry on 180-Day Exclusivity," Duane Morris Alert, March 1, 2017
• Co-author, "FDA Issues Final Guidance on Quality Agreements in Arrangements for Contract Manufacturing of Drugs," Duane Morris Alert, January 3, 2017
• Co-author, "FDA Issues Final Hatch-Waxman Regulations," Duane Morris Alert, October 7, 2016
• Co-author, "FDA Issues Guidance on Self-Identification of Generic Drug Facilities," Duane Morris Alert, October 6, 2016
• Co-author, "FDA Issues Draft Guidance on Data Integrity and Compliance with CGMP," Duane Morris Alert, May 3, 2016
• Co-author, "FDA Publishes Draft Guidance on Abuse-Deterrence Testing of Generic Solid Oral Opioid Drug Products," Duane Morris Alert, April 22, 2016
• Co-author, "FDA Implements Expedited Review of ANDA Submissions for 'Sole-source' Drug Products," Duane Morris Alert, March 31, 2016
• Co-author, "FDA Proposed Rule on Fixed-Combination and Co-Packaged Drugs," Duane Morris Alert, March 16, 2016
• Co-author, "Statutory and Regulatory Control for Drug Companies," Pharmaceutical and Medical Device Law, 2015
• Co-author, "Generics," Bringing Your Pharmaceutical Drug to Market, April 2015
• Co-author, "Chapter 11, Generic Drugs: ANDAs, Section 505 (b)(2) Applications, Patents, and Exclusivities," Food and Drug Law and Regulation, 3rd Edition, March 2015
• Co-author, "FDA Issues Additional Guidances on Implementation of Drug Supply Chain Security Act," Duane Morris Alert, February 25, 2015
• Co-author, "FDA Opens Plan to Let Generic Drug Manufacturers Update Labels to Debate," Duane Morris Alert, February 24, 2015
• Co-author, "FDA Establishes the Office of Pharmaceutical Quality," Duane Morris Alert, February 23, 2015
• Co-author, "FDA's Final Guidance on the Circumstances That Constitute Interference with a Drug Inspection," Duane Morris Alert, December 23, 2014
• Co-author, "Compounding Pharmacy Co-Owner Pleads Guilty to Misdemeanor Criminal Violations of the Food, Drug, and Cosmetic Act," Duane Morris Alert, December 22, 2014
• Co-author, "FDA Policy Aims to Smooth Generic Access to Samples of Branded Drugs Subject to REMS Use Restrictions," Duane Morris Alert, December 16, 2014
• Co-author, "FDA Report on Standardizing and Evaluating Risk Evaluation and Mitigation Strategies (REMS)," Duane Morris Alert, December 1, 2014
• Co-author, "FDA Publishes Second Draft Guidance for Further Clarification of Drug Supply Chain Security Act," Duane Morris Alert, November 17, 2014
• Co-author, "FDA's Final Guidance on Determination of Five-Year NCE Exclusivity for Certain Fixed-Combination Drug Products Under Federal FDCA," Duane Morris Alert, November 10, 2014
• Co-author, "DEA Releases Final Rule on Disposal of Controlled Substances," Duane Morris Alert, September 29, 2014
• Co-author, "FDA Declines to Issue Rulemaking for Section 505(b)(2) NDA Therapeutic Equivalence Ratings," Duane Morris Alert, August 11, 2014
• Co-author, "FDA Issues Draft Guidances for Prior Approval Supplements and Amendments / Easily Correctable Deficiencies Under GDUFA," Duane Morris Alert, August 4, 2014
• Co-author, "FDA Issues Draft Guidance for Identification and Notification of Suspect Products," Duane Morris Alert, June 24, 2014
• Co-author, "FDA Releases Guidance for Industry on ANDAs: Stability Testing of Drug Substances and Products, Questions and Answers," Duane Morris Alert, June 20, 2014
• Co-author, "FDA Seeks Information for Implementation of Drug Supply Chain Security Act," Duane Morris Alert, April 11, 2014
• Co-author, "Chapter 8: Krelec et al. v. Mutual Pharmaceuticals Co., Inc.," Top 20 Food and Drug Cases, 2013 & Cases to Watch 2014, January 2014
• Co-author, "Statutory and Regulatory Controls for Drug Development," Chapter 1, Pharmaceutical Law: Regulation of Research, Development, and Marketing, 2013 Cumulative Supplement, Bloomberg BNA, 2013
• Co-author, "FDA's New Interpretation of the Five-Year NCE Exclusivity Provisions of Federal Food, Drug, and Cosmetic Act," Duane Morris Alert, February 26, 2014
• Co-author, "FDA's Guidance for Industry Concerning Receipt Dates," Duane Morris Alert, February 14, 2014
• Co-author, "FDA Issues Proposed Rules That Give FDA Administrative Detention Authority with Respect to Drugs," Duane Morris Alert, July 17, 2013
• Co-author, "CMS Lets the Sun Shine Down," FDLI Update, May/June 2013
• Co-author, "FDA Issues Guidance Detailing Specific Requirements for Quality Agreements for Commercial Drug Manufacturing," Duane Morris Alert, June 18, 2013
• Co-author, "CMS Publishes Physician Payment Sunshine Rules; Manufacturers and Group Purchasing Organizations Are Required to Submit Detailed Annual Reports," Duane Morris Alert, February 25, 2013
• "United States v. Caronia: A Brief Look at the Broader Implications for the Food Industry," FDLI Update, March/April 2013
• Co-author, "Research-Related Payments and the Physician Payment Sunshine Act: How Reporting Works and What Applicable Manufacturers Should Consider," Duane Morris Alert, March 6, 2013; republished in Healthcare Law360, March 19, 2013
• "Federal Trade Commission vs. Watson: The Supreme Court Takes Up 'Reverse Payments'," Health Care Law Monthly, February 2013
• Co-author, "FDA Suspends Sunland, Inc.; Major Peanut Butter Producer Hit with First Food Facility Suspension Under the Food Safety Modernization Act of 2011," Duane Morris Alert, November 30, 2012; republished by Life Sciences Law360, December 12, 2012
• Co-author, "FDA Issues Guidance for Industry on Generic Drug User Fee Amendments of 2012: Q&A," Duane Morris Alert, August 29, 2012
• Co-author, "FDA's Animal Generic Drug User Fee Rates and Payment Procedures for Fiscal Year 2013," Duane Morris Alert, August 8, 2012
• Co-author, "Third Circuit Holds That Settlement Agreements Containing Payments from the Innovator to the Generic Challenger May Violate Antitrust Laws," Duane Morris Alert, July 23, 2012
• "OIG for HHS Publishes Solicitation of Information and Recommendations for Revising Its Provider Self-Disclosure Protocol," Duane Morris Alert, June 22, 2012
• Co-author, "CMS Delays Data Collection Under ACA's Physician Payments Sunshine Act to January 1, 2013," Duane Morris Alert, May 9, 2012
• Co-author, "FDA Issues Draft Guidance on Affordable Care Act Prescription Drug Sample Transparency Program: Reporting Deadline Informally Extended to October 1, 2012," Duane Morris Alert, April 4, 2012
• "Not Just the FTC Anymore: California's Top Court to Weigh In on 'Pay for Delay'," GenericsWeb INNsight, March 2012
• Co-author, "Affordable Care Act's Prescription Drug Sample Transparency Program Set to Go into Effect April 1, 2012," Duane Morris Alert, March 13, 2012
• Co-author, "Supreme Court Addresses Whether Supremacy Clause Provides Private Right of Action to Challenge Medicaid Cuts in Douglas v. Independent Living Center," Duane Morris Alert, March 12, 2012
• Co-author, "Centers for Medicare and Medicaid Services Releases Proposed Rule on Reporting and Returning of Overpayments," Duane Morris Alert, March 8, 2012
• "FDA Issues Draft Guidance for Notification of Issues That May Result in Prescription Drug Shortage," Duane Morris Alert, March 1, 2012
• "U.S. Court of Appeals for the District of Columbia Circuit Determines That FDA Warning Letters Are Not Final Agency Action," Duane Morris Alert, January 20, 2012
• "FDA Issues Proposed Rule Regarding Citizen Petitions and PSAs Related to Section 505(b)(2) Applications or ANDAs," Duane Morris Alert, January 4, 2012
• Co-author, "A Response to Terry Mahn's Is It Time for FDA to Revise Its Orange Book Rules to Deal with 'Skinny-Labled' Generic Drugs?" FDLI's Food and Drug Policy Forum, December 14, 2011
• "Federal Pre-Emption Under the Food, Drug & Cosmetic Act from Medtronic, Inc. v. Lohr; Pliva, Inc. v. Mensing," Bender's Health Care Law Monthly, September 1, 2011
• Co-author, "U.S. Supreme Court Holds That State-Law-Based Failure-to-Warn Claims Are Federally Preempted Against Generic Drug Manufacturers," Duane Morris Alert, June 23, 2011
• Co-author, "FDA's Guidelines for Petitions Filed Under Section 505(q) of Food, Drug, and Cosmetic Act," Duane Morris Alert, June 16, 2011
• Co-author, "CMS: Proposed Rule for States on Medicaid Fee-for-Service Rate-Setting Procedures," Duane Morris Alert, May 12, 2011
• Co-author, "FDA: Liquid OTC Drugs with Poorly Labeled Measuring Devices May Constitute Misbranding," Duane Morris Alert, May 10, 2011
• "FDA's Interim Final Rules for the Food Safety Modernization Act," Duane Morris Alert, May 6, 2011
• Co-author, "FDA: Processing and Reprocessing Medical Devices in Healthcare Settings," Duane Morris Alert, May 4, 2011
• "FDA Requests Comments on Improving Regulatory Rules," Duane Morris Alert, May 3, 2011
• Co-author, "Labeling Changes for Prescription Drugs After New Safety Information: FDA's Draft Guidance," Duane Morris Alert, April 28, 2011
• Co-author, "Long-term Care Pharmacy Joint Venture May Violate Anti-kickback Laws: OIG Issues Advisory Opinion 11-03," Duane Morris Alert, April 20, 2011
• Co-author, "FDA Drafts Pharma Industry Guidance for Postmarketing Studies and Clinical Trials," Duane Morris Alert, April 14, 2011
• "Supreme Court Decides 340B Entities Cannot Sue Pharmaceutical Manufacturers for Noncompliance with Pharmaceutical Pricing Agreement," Duane Morris Alert, April 1, 2011
• Co-author, "Pennsylvania District Court Prevents Disclosure of Hundreds of Confidential Settlement Agreements," Duane Morris Alert, March 24, 2011
• Co-author, "FDA Announces Draft Guidance for Industry on User Fee Waivers, Reductions and Refunds for Drug and Biological Products," Duane Morris Alert, March 17, 2011
• "FDA Removes More Than 500 Unapproved Prescription Cough, Cold and Allergy Drug Products from the U.S. Market," Duane Morris Alert, March 9, 2011
• "Fifth Circuit Rules in Favor of Compounding Pharmacies, in Medical Center Pharmacy v. Holder," Duane Morris Alert, March 4, 2011
• "CMS Issues Proposed Rule Prohibiting Medicaid Payments for Healthcare-Acquired Conditions," Duane Morris Alert, February 25, 2011
• "FDA Extends Comment Period for Strategies to Address Animal Drug Products Marketed in the U.S. Without Approval," Duane Morris Alert, February 23, 2011
• "FDA Issues "Non-Binding" Park Doctrine Criteria for Potential Referral of "Responsible Corporate Officials" for Prosecution for Alleged Violations of the Food, Drug and Cosmetic Act," Duane Morris Alert, February 10, 2011
• Co-author, "FDA Issues Guidance on Dietary Supplement cGMP Regulations," Duane Morris Alert, January 27, 2011
• Co-author, "CMS Proposes New Rule on Patient Quality-of-Care Complaints," Duane Morris Alert, February 9, 2011
• Co-author, "The FTC Revised Endorsement and Testimonial Guides--Advertisers of Dietary Supplements, Be Aware!," FDLI Update, November/December 2010
• "Responding to New Food and Drug Case Law and Regulations," Chapter in Recent Developments in Food and Drug Law: Leading Lawyers on Analyzing Recent Litigation, Navigating Increased Enforcement Efforts, and Complying with FDA Requirements (Inside the Minds), Aspatore Books, 2010
• "U.S. Military's TRICARE Health Program Issues Retail Pharmacy Refund Rule for Drug Prescriptions," Duane Morris Alert, October 19, 2010
• Co-author, "FDA to Increase Criminal Prosecution of Corporate Officials in the Pharmaceutical Industry," Duane Morris Alert, March 11, 2010
• Co-author, "How Hard Should It Be to Imprison Someone for Telling the Truth?" FDLI Update, September/October 2009
• "FDA Issues Draft Guidance Regarding the Incorporation of Physical-Chemical Identifiers into Solid Oral Dosage Form Drug Products for Anticounterfeiting," Duane Morris Alert, July 17, 2009
• "FDA Seeks Comments on "Risk Information" in Advertising from Pharmaceutical and Medical Device Manufacturers," Duane Morris Alert, May 28, 2009
• "The First Amendment and Off-Label Promotion: Why the Court in United States v. Caronia Got it Wrong," Health Care Law Monthly, April 2009
• "FDA Issues Draft Guidance Regarding the Submission of Summary Bioequivalence Data for Abbreviated New Drug Applications," Duane Morris Alert, April 17, 2009
• "U.S. Department of Justice and the Office of the Inspector General Plan to Target Physicians' Relationships with Pharmaceutical Companies and Medical Device Manufacturers," Duane Morris Alert, March 6, 2009
• "DEA Issues Proposed Rule on E-prescribing," The Journal of Medical Practice Management, January/February 2009
• "FDA Issues Draft Guidance on Citizen's Petitions," Duane Morris Alert, January 29, 2009
• "FDA Issues Final Guidance for Industry on Good Reprint Practices for the Distribution of Medical Journal Articles," Duane Morris Alert, January 22, 2009
• "FDA Issues Notice of Secure Supply Chain Pilot Program," Duane Morris Alert, January 21, 2009
• "FDA and Other Agencies Issue a Draft Guidance for Good Importer Practices," Duane Morris Alert, January 21, 2009
• "Office of Inspector General Solicits Comments Regarding New Safe Harbors and Special Fraud Alerts," Duane Morris Alert, January 5, 2009
• "OIG Issues Final Supplemental Compliance Program Guidance for Nursing Facilities," Duane Morris Alert, October 2, 2008
• "Ninth Circuit Opens Door to Pricing Suits by 340B Entities," Duane Morris Alert, September 3, 2008
• "DEA Issues Proposed Rule on E-Prescribing," Duane Morris Alert, July 10, 2008
• "Settlement Bans Health Care Provider's Participation in Federally Funded Plans," Duane Morris Alert, June 25, 2008
• "OIG Reports on FDA Generic Drug Review Process," Duane Morris Alert, June 23, 2008
• "Nursing Homes Be Aware: OIG Issues Supplemental Compliance Program Guidance," Duane Morris Alert, May 21, 2008
• "FDA Announces Draft Prescription Drug User Fee Act for Drug Safety Five-Year Plan," Duane Morris Alert, May 6, 2008

Selected Speaking Engagements

• Speaker, "Practical Impacts of Recent FTC Updates," Association of Corporate Counsel, September 12, 2024
• Speaker, "When Things Go Wrong: Navigating Enforcement When the FDA, SEC, and DOJ Are All Involved," MassMEDIC Regulatory Roundup, November 15, 2023
• Presenter, "The Data Privacy and Security Landscape: Let s Talk About Tech - Wearable Fitness and Health Tech," Duane Morris LLP Webinar, November 6, 2023
• Speaker, "Recent Developments on the 'Fraud on the FDA' Theory of False Claim Liability," MassMedic Reguatory Roundup Event, Webinar, February 16, 2023
• Moderator, "False Claims Act and Fraud-On-The-FDA Theory for Liability," Food and Drug Law Institute, Washington D.C., December 7, 2022
• Instructor, "Introduction to Drug Law and Regulation Violations and Enforcement," Food and Drug Law Institute Virtual Course, April 28, 2022
• Presenter, "COVID-19: From Sea to Shining Sea: A Quick Update of U.S. and International COVID-Related Restrictions," Duane Morris LLP, Webinar, December 11, 2020
• Moderator, "Legal, Regulatory, and Economic Challenges Facing Cannabis Growers," Legal and Practical Issues in the Evolving World of Cannabis Regulation, Food and Drug Institute (FDLI), December 3, 2021
• Speaker, "Entering the U.S. Market for European Pharma: Essential IP and Regulatory Considerations," Duane Morris Webinar, June 23, 2020
• Speaker, "Virtual Happy Hour with Update Magazine Authors Rick Ball and Justin Stern," Food and Drug Law Institute, April 30, 2020
• Speaker, "How COVID-19 Is Affecting Life Sciences and Medical Technologies," Duane Morris Webinar, April 16, 2020
• Speaker, "Food Enforcement and Compliance Conference," Food and Drug Law Institute, Washington D.C., March 26, 2020
• Moderator, "The USDA Hemp Interim Final Rule: Status, Remaining Issues, and Next Steps," Food and Drug Law Institute, Webinar, January 21, 2020
• Speaker, "Developments in Enforcement of CBD and Cannabis Products," FDLI's Enforcement, Litigation, and Compliance Conference, Renaissance Downtown Hotel, Washington D.C., December 11-12, 2019
• Speaker, "Legal and Practical Issues in the Evolving World of Cannabis Regulation," Food and Drug Law Institute, Washington D.C., November 18, 2019

• Speaker, "How to Free CBD from the FDA Grasp: Call It GRAS," The Cannabis Reporter Radio Show Podcast, May 20, 2019

• Speaker, "Introduction to Drug, Biologics and Biosimilars Law and Regulation," FDLI's Introduction to Drug, Biologics and Biosimilars Law and Regulation, Boston, July 24, 2019

• Presenter, "Single, Shared System Risk Evaluation and Mitigation Strategies: Opportunities and Challenges," Food and Drug Law Institute, Webinar, May 14, 2019

• Panelist, "Entering the U.S. Market: Considerations for Strategic Transactions and Collaborations," Innovation Across Borders: Strategies for Chinese Life Sciences Companies Doing Business in the U.S., Shanghai, March 7, 2019

• Moderator, "Innovation Across Borders: Strategies for U.S. and Chinese Companies in the Health Sciences Industry," Duane Morris LLP and Chinese Biopharmaceutical Association (USA), January 8, 2019 

• Speaker, "Emerging Legal Issues in IP and Paragraph IV Litigation," GRx+Biosims Conference, Hilton Baltimore, Baltimore, Maryland, September 6, 2018

• Speaker, "Recent FDA Guidance on General Principles for Evaluating the Abuse Deterrence of Generic Solid Oral Opioid Drug Products," CBI Abuse-Deterrent Formulations Summit, Silver Spring, Maryland, March 13, 2018

• Speaker, "Enforcement Throughout the Supply Chain," Food and Drug Law Institute, December 6, 2017

• Speaker, "The FDA Reauthorization Act and GDUFA II: What You Need to Know," Food and Drug Law Institute, Live Webinar, November 14, 2017
• Panelist, "Medical Products: FDA and Opioid Use," Food and Drug Law Journal Symposium, Washington D.C., October 20, 2017
• Speaker, "Violations and Enforcement," FDLI Introduction to U.S. Drug Law and Regulation, Boston, June 15, 2017
• Speaker, "Interpretation of the FDA Data Integrity Draft Guidance and Preparing for Compliance," Food and Drug Law Institute's Enforcement Conference, December 7, 2016
• Speaker, "The Abbreviated NDA (ANDA), 505(b)(2) Applications, and Patent and Exclusivity Issues," Food and Drug Law Institute's Introduction to Drug Law and Regulation Course: The Legal Framework for Drug Regulation, Washington, D.C., April 12-13, 2016
• Speaker, "Recent Updates and Stories from the Trenches Pathways to Bringing Your Generic Drug to the U.S. Market: Paragraph IV Certifications, Hatch–Waxman Litigation, Section 505(b)(2), and the Biosimiliars Patent Dance," IP Life Sciences Exchange, Frankfurt, Germany, November 10, 2015
• Speaker, "GDUFA Inspections, and Labeling, Oh My: A Look at the Regulatory Challenges and Opportunities for the Generic Industry Operating in the U.S. in 2015," World Generic Medicines Congress Europe 2015 Conference, Madrid, March 4-5, 2015
• Moderator, "The Present Part 2: Generic Industry Challenges and Current Issues," Food and Drug Law Institute's Conference on Celebrating the 30th Anniversary of the Hatch-Waxman Amendments: The Past, Present and Future of Generic Drugs, Washington D.C., September 18, 2014
• Moderator, "Doing Business With India: Latest Developments in Pharmaceutical Regulation," FDLI Webinar, June 27, 2014
• Presenter, "Introduction to Drug Law and Regulation: The Legal Framework for Drug Regulation," The Food and Drug Law Institute, November 7, 2013
• Moderator, "Practical Impact of Caronia and First Amendment Implications," Food and Drug Law Annual Conference, Washington, D.C., April 23, 2013
• Presenter, "Violations and Enforcement," Food and Drug Law Institute's Conference on Introduction to Drug Law and Regulation: The Legal Framework for Drug Regulation, Washington, D.C., April 4, 2013
• Speaker, "Hot Topics in Food, Medical Devices and Pharmaceuticals," Food and Drug Law Institute's U.S. & Brazil: Navigating New Frontiers in Pharmaceutical, Medical Device and Food Law and Regulation Conference, Sao Paolo, Brazil, September 10, 2012
• Speaker, American Health Lawyers Association and Food and Drug Law Institute's Conference on The Intersecting Worlds of Drug, Device, Biologics and Health Law, Washington, D.C., May 22, 2012
• Speaker, "An Exploration of Current Professional Conduct Rules and Ethical Issues Raised by Lauren Stevens and Similar Cases," Food and Drug Law Institute's 55th Annual Conference, Washington D.C., April 25, 2012
• Speaker, "Biosimilars: Viewing the New Guidances Through an International Lens," Food and Drug Law Institute Webinar, March 28, 2012
• Presenter, Introduction to Medical Device Law and Regulation: How the Government Regulates the Medical Device Industry, Washington D.C.. March 12, 2012
• Speaker, Food and Drug Law Institute's U.S.-China Food and Drug Law Conference, Beijing, June 2011
• Speaker, American Conference Institute Summit on Drug and Device Product Recalls, Philadelphia, March 2011
• Visiting Lecturer, University of Florida School of Pharmacy, Masters in Pharmacy, March 2011
• Speaker, Food and Drug Law Institute's Introduction to Drug Law and Regulation, Washington, D.C., November 2010
• Speaker, Food and Drug Law Institute's Introduction to Drug Law and Regulation, Washington, D.C., October 2009
• Speaker, Food and Drug Law Annual Conference, Washington, D.C., April 22-23, 2009
• Speaker, Food and Drug Law Institute's Introduction to Drug Law and Regulation, Washington, D.C., June 26-27, 2008
• Speaker, "E-Discovery Ramifications of the Qualcomm Case," Webinar, March 18, 2008
• Speaker, Food and Drug Law Institute's Introduction to Drug Law, Import and Export Issues, January 19, 2007
• Speaker, Food and Drug Law Institute's Introduction to Drug Law, Enforcement, January 19, 2007