Overview of FDA 351 vs 361 Classifications on Biologics and HCTPs
The “Deemed to be a License” Provision of the BPCI Act (31of33) Quality – Oct. 16-17, 2019
March 2020 Transition Under the BPCI Act: Impact on Generics
CDER’s Role in Public Health Emergency Response and Medical Countermeasure Development
Biosimilars: Totality of the Evidence in Biosimilar Development
Regulatory Highlights for Biosimilars and Interchangeables (9of15) REdI – May 29-30, 2019
Ep:351 YOU WILL LOVE THIS "ANTI-SCIENCE" RANT
An Overview of Pre-License Inspections for Biotech Products (5/15) Global Quality
FDA's New Take on Regenerative Medicine 2023
Labeling for Biological Products (11of19) PDL – Dec.4-5, 2019
FDA’s Efforts to Facilitate the Development of Safe & Effective Regenerative Medicine Products
Paul Melmeyer : Orphan Drug Act
2019 USA Regenerative Medicine Regulatory Update: Don Buford, MD
FDA Drug Topics: Development and U.S. Regulation of Preventative Vaccines - September 27, 2022
The Health & Care Act: What's going on? EveryDoctor Briefing 24.05.22
ACA Enrollment from CRTW 351
US FDA Standards Overview
Biosimilars and Interchangeables - Regulatory Highlights (27of33) Quality – Oct. 16-17, 2019
3.1 - Steve Wilson - Research Questions in Environmental Public Health
Committee for Health - Tuesday 7 January 2025