Despite few public announcements and industry concerns, FDA's Office of Pharmaceutical Quality director says program is not dead.
The US FDA's quality metrics program for drug manufacturing facilities may be quiet and potentially undergoing some changes, but has not been abandoned.
Office of Pharmaceutical Quality Director Michael Kopcha said the agency continues to review the myriad of comments received from industry...
While the first six months of the year saw eight new drugs targeting a range of diseases enter the European Medicines Agency’s priority medicines scheme, and three PRIME-designated treatments go on to win EU marketing approval, use of the accelerated assessment mechanism appears to be limited.
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The transparency initiative collects CRLs already made public in approval packages on its drugs@fda site to post on the openFDA public portal.
