Regulatory Blog

The U.S. FDA has released a draft guidance titled Cross-Center Master Files: Where to Submit , issued in November 2025 addressing a longstanding challenge in regulatory operations: determining which FDA center  should host a master file (MF) when the file must support multiple regulatory submissions across different FDA centers. This guidance aims to reduce industry confusion, avoid duplicate submissions, and streamline review processes when MFs are used across drugs, biolog

The U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research and Center for Biologics Evaluation and Research...

Health Canada recently (26 June, 2023) published an updated guidance on "Guidance on Procedures and Administrative Requirements for...