The Center for Sharing Public Health Services
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
An Overview of Pre-License Inspections for Biotech Products (5/15) Global Quality
Biosimilars: Totality of the Evidence in Biosimilar Development
Regulatory Highlights for Biosimilars and Interchangeables (9of15) REdI – May 29-30, 2019
Labeling for Biological Products (11of19) PDL – Dec.4-5, 2019
Paul Melmeyer : Orphan Drug Act
FDA Drug Topics: Development and U.S. Regulation of Preventative Vaccines - September 27, 2022
US FDA Standards Overview
Quality Considerations for Transition Biological Products (32of33) Quality – Oct. 16-17, 2019
Public Health PBRN Monthly Meeting 12-20-12
Protecting Public Health Authority: Law, Equity & the Public Health Workforce
WSCS 2014: CLINICIANS GUIDE TO AVOIDING COMPLIANCE ISSUES WITH THE FDA AND FTC
FDA’s Efforts to Facilitate the Development of Safe & Effective Regenerative Medicine Products
Biosimilars and Interchangeables - Regulatory Highlights (27of33) Quality – Oct. 16-17, 2019
Importing and Exporting CBER Regulated Products
You Won't Eat GMO But You'll Put This In Your Eye - Part 1
