Labeling for Prescription Drugs, Biologics and Combination Products – Webinar Recording/Transcript

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Labeling for Prescription Drugs, Biologics and Combination Products: Complying with FDA’s Most Recent IFU Guidance

The FDA guidance on Instructions for Use (IFU) issued in July 2019 aims to make labeling of prescription drugs, biologics and combination products clearer and more helpful to patients. But this could have implications for your business’ NDAs and BLAs.

If you’re unsure how to proceed, you’re not alone. In this presentation, Alan G. Minsk, Esq. — a partner and leader of the Food & Drug Practice Team of Arnall Golden Gregory LLP — will clarify the new guidance and explain how to comply with it, focusing on the issues you must consider as you implement changes to your IFUs.

Presentation Takeaways:

  • Why FDA issued the draft guidance and its importance to regulatory, quality and compliance specialists, including the content and format concerns of FDA in general and details necessary for safe and effective use
  • What kind of language IFUs should be written in to be patient friendly
  • What the guidance recommends in terms of voice, commands and sentences
  • Examples of sample labeling that covers all elements of an IFU from dosage and usage to storage and disposal
  • What kinds of recommendations FDA makes in terms of design and layout, such as the use of easy-to-read fonts, sequential numbering and white space
  • Some practical considerations on patient labeling, from a business perspective

If you are at all unclear how to implement this guidance and change your IFUs to include what FDA considers to be “clear, concise information that is easily understood,” you listen to this presentation. Your NDAs and BLAs depend on it.

  • Regulatory Affairs Professionals
  • Quality Assurance Professionals
  • Marketing Professionals
  • Attorneys
  • Consultants

Meet Your Presenter
Alan G. Minsk, Esq. is a partner and leader of the Food & Drug Practice Team of Arnall Golden Gregory LLP, an Am Law 200 law firm located in Atlanta, Georgia and Washington, D.C. He advises pharmaceutical, biologic, medical device, cosmetic and food companies (including dietary supplements and medical foods) on all legal and regulatory matters relating to the U.S. Food and Drug Administration. Mr. Minsk counsels clients on a wide variety of FDA-related issues including regulatory strategies and life cycle management, combination products, FDA enforcement, FDA inspections, compliance, market exclusivity, product promotion and advertising, clinical trials and imports and exports. Mr. Minsk conducts in-house training on FDA topics. He also serves as general counsel of PDMA Alliance Inc., a pharmaceutical trade organization focused on compliance with the Prescription Drug Marketing Act and sample accountability. An active thought leader, Mr. Minsk has written book chapters, articles and bulletins on a wide variety of issues, including 505(b)(2) NDAs, orphan drugs, product promotion, quality agreements, compliance, and medical device regulation. He currently serves on a number of editorial boards for professional publications, including the RAPS Focus magazine and the Food and Law Drug Institute’s Food and Drug Journal. Mr. Minsk is nationally recognized by Chambers USA for “Life Sciences: Regulatory/Compliance,” has been selected for inclusion in the international publication of Who’s Who Legal for “Life Sciences: Regulatory”, and is recognized by Best Lawyers for “FDA Law.”