Federal Register notice: FDA determines for patent extension purposes the regulatory review period for Nabriva Therapeutics Xenleta injection (lefamul...
Federal Register notice: FDA determines for patent extension purposes the regulatory review period for Impact Biomedicines Inrebic (fedratinib), indic...
The International Council on Harmonizations looks at changes it must make to evolve with the process of drug development in a changing healthcare syst...
CDER appoints M. Khair ElZarrad as director of the Office of Medical Policy.
Public Citizen calls on FDA to ensure that the membership of an advisory committee considering whether Covis Makena should be withdrawn is fair and ba...
Hulu launches an eight-part series on the Oxycontin epidemic that graphically lambastes Purdue Pharma but soft-pedals FDAs enabling role.
The Government Accountability Office says FDA may be challenged in resuming routine surveillance inspections of vaccine and allergenic manufacturing f...
FDA contracts with the Yale School of Medicine to promote clinical trial awareness and access to underrepresented minorities.