Pharmaceutical Technology spoke with Monica Caphart, FDA, and Susan Schniepp, PDA, about the 2015 PDA/FDA Joint Regulatory Conference taking place in Washington, DC, in September.
Monica Caphart, leveraging and collaboration program manager with the Division of Human Resource Development at FDA, and Susan Schniepp, chair of PDA Regulatory Affairs and Quality Advisory Board, spoke with BioPharm International about the theme of the 2015 PDA/FDA Joint Regulatory Conference, how legislative tools have improved the quality of drug products, and what attendees can expect from conference sessions and regulatory authority interactions.
The 2015 PDA/FDA Joint Regulatory Conference will take place in Washington, DC, September 28–30, 2015.
FDA Reopens Comment Period on HCP Immunogenicity Risk of Follow-on Recombinant Peptides
January 2nd 2025FDA is reopening the comment period for the Federal Register Notice, “Evaluating the Immunogenicity Risk of Host Cell Proteins in Follow-on Recombinant Peptide Products: Establishment of a Public Docket: Request for Information and Comments”, until March 3, 2025.