Federal Register notice: FDA renews its National Mammography Quality Assurance Advisory Committee for an additional two years beyond its charter expir...
FDA cautions that it may only be able to give the green light for booster shots later this month to those vaccinated with the Pfizer/BioNTech Covid-19...
CDER Office of Generic Drugs reaches the milestone of approving more than 100 generic drug applications with a Competitive Generic Therapy designation...
FDA announces a 9/17 Vaccines and Related Biological Products Advisory Committee meeting to discuss Pfizer-BioNTechs supplemental BLA seeking approval...
FDA approves Janssens Invega Hafyera six-month atypical antipsychotic injection for some adult schizophrenia patients.
FDA posts a Federal Register notice of its intent to not approve an Intarcia NDA for a diabetes drug/device combination product.
Federal Register notice: FDA sends to OMB an information collection revision entitled Medical Device User Fee Cover Sheet, Form FDA 3601 and Device Fa...
Federal Register notice: FDA seeks comments on an information collection revision entitled Drug Supply Chain Security Act Implementation.