Regulatory Update — Week of Feb. 12, 2024

Over the past week, the FDA issued a final rule on BLAs and master files. Final Guidance was issued on charging for investigational drugs under an IND. Draft guidance was issued on use of data monitoring committees. Product specific guidances were published. The agency also announced continuation of its site visit training program for its regulatory project managers, extended the comment period for the draft guidance on master protocols for drug and biological product development and amended a request for nominations for voting members for the Genetic Metabolic Diseases advisory committee.
Source: Drug Industry Daily