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

CDER Guidance Agenda

Medline is recalling certain Medline Kits containing recalled Medtronic DLP Left Heart Vent Catheters as the catheter may not retain its shape.

This page contains the PCAC roster, which lists the current members and the current number of vacancies for the committee.

This guidance provides recommendations for increasing enrollment of females in clinical trials, analyzing and interpreting sex-specific data, and including sex-specific information in regulatory submissions of medical products

Laurus Labs Limited – 01/31/2025. Country: India. Record Type: 483

Genzyme Ireland Limited – 01/17/2025. Country: Ireland. Record Type: 483