ACI’s 43rd FDA Boot Camp – New York City Edition

The American Conference Institute’s popular “FDA Boot Camp” – now in its 43rd iteration – is scheduled to take place from March 19-20, 2025, at the NY Bar Association in New York, NY . The conference is billed as the premier event to provide folks with a roadmap to navigate the difficult terrain of FDA regulatory law.  And it is exactly that!

The conference equips legal professionals without prior regulatory experience, as well as life sciences executives involved with FDA-regulated products, with a comprehensive understanding of fundamental FDA principles.  This is achieved through firsthand insights, real-world examples, and case studies from FDA-regulated products.

This year’s conference co-chairs are Hyman, Phelps & McNamara, P.C.’s Kurt R. Karst, and Morgan, Lewis & Bockius LLP’s Maarika L. Kimbrell. They will be joined by an esteemed panel of top FDA regulatory leaders covering essential topics, including:

• Navigating the Approval Process for Drugs and Biologics
• Clarifying the Clinical Trial Process for Drugs and Biologics
• Understanding the Structure of the FDA and the Roles of Its Three Major Centers: CDER, CBER, and CDRH
• Hatch-Waxman and BPCIA Fundamentals: Understanding Follow-On Products and the Rules for Generic Entry
• Good Manufacturing Practices (cGMPs): Discovering the Unique Role of cGMPs in the Post-Approval Process
• Advertising, Promotions, and Related First Amendment Concerns
• Understanding the Scope of FDA Enforcement Authority and Actions

FDA Law Blog is a conference media partner. As such, we can offer our readers a special 10% discount. The discount code is: D10-999-FDA25.  You can access the conference brochure and sign up for the event here.  We look forward to seeing you at the conference.