Pharmacovigilance

A term that can be applied to the entirety of drug safety oversight, including pre-approval and post-marketing periods.

Drug Safety challenges differ substantially between early development (Phase 1, 2), late stage clinical trials (Phase 3), and the post-marketing period. As expected, these differences are reflected in the concerns of the companies responding to the survey

CLICK HERE FOR THE RESULTS OF THE IND SAFETY FINAL RULE SURVEY

These nuances are fairly well known in industry drug safety circles.

What is less known however is the impact of FDA’s recent movements with respect to the IND Safety Final Rule: the June 2021 Draft Guidance:

Sponsor Responsibilities - Safety Reporting Requirements and Safety Assessment for IND and Bioavailability/Bioequivalence Studies.

CLICK HERE FOR GUIDANCE DOCUMENT