Teva Takes Swipe At Mylan In Seventh Petition To Block Copaxone Generics

The transparency initiative collects CRLs already made public in approval packages on its drugs@fda site to post on the openFDA public portal.

FDA staff are trying to plan for program implementation in the absence of critical eligibility and other details, although guidance may be coming soon.

US FDA would receive more funding for fiscal year 2026 in the Senate appropriations bill than its House counterpart, including $10m for unannounced foreign inspections.

In this first of a two-part series of articles, US Pharmacopeia CEO Ronald T. Piervincenzi tells the Pink Sheet how the use of alternatives to animal testing in drug development is gaining traction and discusses the challenges that exist.