FDA appoints CDER Office of Study Integrity and Surveillance deputy director Sally Choe as permanent director of the Office of Generic Drugs.
FDA grants Neurotech Pharmaceuticals a fast track designation for Renexus (NT-501) for treating macular telangiectasia type 2.
Federal Register notice: FDA sends to OMB an information collection extension entitled Investigational New Drug Application 21 CFR Part 312.
FDA releases its latest batch of Warning Letters that includes one medical product company McKesson.
FDA clears a LaserOptek 510(k) for its PicoLO picosecond Nd:YAG for use in dermatology and general and plastic surgery.
FDA accepts for priority review a Merck supplemental BLA for Keytruda (pembrolizumab), its anti-PD-1 therapy as monotherapy or in combination with pla...
Federal Register notice: FDA has determined that the regulatory review period for Sareptas Duchenne drug Exondys 51 (eteplirsen).
FDA says it is working on a new plan to modernize dietary supplement regulation and oversight.