FDA is implementing a reorganization proposed by outgoing commissioner Scott Gottlieb.
Federal Register notice: FDA awards Vertex Pharmaceutical a priority review voucher after it determined that a qualified rare pediatric disease produc...
Departing FDA commissioner Scott Gottlieb tells a sit-down chat session that the most enduring accomplishment at the agency during his almost two-year...
Amarin files a supplemental NDA seeking an expanded indication for Vascepa (icosapent ethyl) capsules based on data from the REDUCE-IT cardiovascular ...
Bloomberg News says FDA is working on changes to drug manufacturing regulations to reduce problems with contaminated active pharmaceutical ingredients...
DLA Piper attorneys say a 2nd Circuit Court of Appeals decision in a case involving Bristol-Myers Squibb and Pfizers Eliquis strengthens preemption la...
Federal Register proposed rule: FDA proposes to update the mammography regulations that were issued under the Mammography Quality Standards Act of 199...
Federal Register notice: FDA has announced the renewal of the Cellular, Tissue and Gene Therapies Advisory Committee for an additional two years.