Federal Register notice: FDA announces that at the companys request it is withdrawing the approval of a Bayer NDA for Baycol (cerivastatin sodium) tab...
CDER issues a MAPP on the process for applying for emergency use of an investigational new drug.
FDA clears a Globus Medical 510(k) for the Excelsius GPS, a robotic guidance and navigation system for orthopedic and neurosurgical procedures.
Lachman Consultants says it has learned that FDA plans to issue two documents by years end on ANDA assessment and review.
FDA tells Valeant Pharmaceuticals that it intends to issue a Voluntary Action Indicated inspection classification for its Bausch + Lomb manufacturing ...
FDA approves Wyeth Pharmaceuticals Besponsa (inotuzumab ozogamicin) for treating adults with relapsed or refractory B-cell precursor acute lymphoblast...
Researchers suggest a way to make the FDA Adverse Event Reporting System more useful.
The Justice Department says Mylan is paying $465 million to resolve a Sanofi-Aventis whistleblower suit alleging that it knowingly falsely labeled its...