A BMJ investigation says a Ventavia Research Group whistleblower informed FDA about multiple irregularities in the companys work testing the Pfizer Co...
FDA chief scientist and Public Health Service Commissioned Corps rear admiral Denise Hinton leaves the agency FDA to serve as deputy Surgeon General.
CDER says it is moving to electronic Certificates of Pharmaceutical Product as of 12/3.
FDA extends to 2/28/22 the PDUFA action date for a Janssen BLA for its cilta-cel multiple myeloma treatment.
FDA warns CellEra about multiple repeat Quality System violations in its as a specification developer and distributor of sterile wound dressings.
Federal Register notice: FDA determines for patent extension purposes the regulatory review period for Sarepta Therapeutics Vyondys 53 (golodirsen).
Federal Register notice: FDA determines for patent restoration purposes the regulatory review period for Biogens Spinraza (nusinersen sodium).
Federal Register notice: FDA determines for patent extension purposes the regulatory review period for Daiichi Sankyos Enhertu.