An Introduction to Biosimilar Product Regulation and Approval Review background and definitions of biologic and biosimilar drugs and new drug application (NDAs) and biologics license application (BLAs). Discuss biosimilar pathways to market and application contents. Learn about the types of meetings available to interact with FDA. Examine interchangeability standards and conditions [...]
Biologics License Applications (BLA): An Introduction Assess historical and current standards of approval. Discuss what standard FDA uses to approve a BLA submitted under section 351(a) of the Public Health Service Act (PHSA). Outline what is in section 351(a) BLA. Understand FDA’s review and decision processes. Andrew Papas , Vice President of [...]
Regenerative Medicine and Advanced Therapies: An Introduction Distinguish between human cellular and tissue-based products (HCT/P). Review the regulatory framework for the regulation of regenerative medicine products and discuss key definitions and eligible therapies. Examine expedited programs for RMATs. Review emerging issues in gene editing, in-office procedures and stem cell manufacturing practices. [...]
Why Attend Agenda All times are in Eastern Daylight Time CLE Monday, September 27 3:15–3:30 PM Welcome and Keynote Introduction Amy Comstock Rick, President & CEO, FDLI 3:30–4:10 PM Keynote Address Claudine Kavanaugh, Director, Office of Nutrition and Food Labeling, Center for Food Safety and Applied Nutrition (CFSAN), [...]
Why Attend Agenda CLE Continuing Legal Education
Top Food and Drug Cases, 2020, & Cases to Watch, 2021 FDLI’s Top Food and Drug Cases is the companion volume to the popular panel at our Annual Conference. Become A Member As a general matter, “looking back at 2020” is a singularly unpleasant prospect for the vast majority [...]
AMG Capital Management, LLC v. Federal Trade Commission T. DANIEL LOGAN & JAQUELINE J. CHAN* Why It Made the List On first glance, a case about the Federal Trade Commission’s (FTC’s) remedies against payday lending may not appear relevant to food and drug law and its practitioners. However, in effect, many agencies pull enforcement [...]
Why Attend Agenda CLE Continuing Legal Education
Why Attend Agenda CLE Tuesday, June 8 11:00–11:45 AM Bonus Session: A Primer on Regenerative Medicine Science and Recent Breakthroughs Heather C. Hatcher, Regulatory Scientist, Womble Bond Dickinson (US) LLP Collin Stabler, Senior Associate, Exponent, Inc. Moderated by Barbara A. Binzak Blumenfeld, Shareholder, Buchanan Ingersoll & Rooney PC [...]
Why Attend Agenda CLE Continuing Legal Education
