Why Attend Agenda subject to change All times are in Eastern Time CLE Tuesday, November 9 4:00 – 4:40 PM FDLI Welcome, Introductions, and Keynote Address Amy Comstock Rick, President & CEO, FDLI Andi Lipstein Fristedt, Deputy Commissioner for Policy, Legislation, and International Affairs, FDA 4:45–5:45 PM [...]
Why Attend Agenda CLE Continuing Legal Education
Why Attend Agenda All times are in Eastern Time CLE Wednesday, October 27 11:00 – 11:50 AM Welcome, Opening Remarks, and Keynote Address Amy Comstock Rick, President & CEO, FDLI Mitchell R. Zeller, Director, Center for Tobacco Products (CTP), FDA 11:55 – 1:00 PM Reactor Panel: [...]
Food and Drug Law Journal | Volume 76 | Number 2
Why Attend Agenda CLE Continuing Legal Education
Why Attend Agenda subject to change All times are in Eastern Daylight Time CLE Wednesday, October 13 10:55 – 11:10 AM Technology and Connection Support Session 11:15 – 11:30 AM FDLI Welcome and Introduction Amy Comstock Rick, President & CEO, FDLI Madhavi Bellamkonda, Director, Regulatory Intelligence & Integration [...]
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), [...]
