Federal Register notice: FDA seeks comments on an information collection extension entitled Reclassification Petitions for Medical Devices.
Federal Register notice: FDA seeks comments on an information collection revision entitled Labeling Requirements for Prescription Drugs.
Federal Register notice: FDA announces a 9/17 Vaccines and Related Biological Products Advisory Committee meeting to discuss a Pfizer-BioNTech supplem...
CDER starts its Novel Excipient Review Pilot Program to foster the development of excipients for when excipient manufacturers and drug developers have...
FDA warns Kaleido Biosciences that it conducted clinical trials on an investigational Covid-19 drug without submitting an IND.
FDA places a clinical hold on a BioMarin gene therapy study to treat adults with phenylketonuria.
FDA accepts for priority review a Global Blood Therapeutics supplemental NDA and a separate NDA for Oxbryta (voxelotor) and its use in treating sickle...
FDA clears a NeuroOne Medical Technologies 510(k) for its Evo sEEG Electrode technology for temporary (less than 24 hours) use for recording, monitori...