FDA expands the emergency use authorization for Pfizer-BioNTechs Covid-19 vaccine to include adolescents aged 12 through 15 years.
FDA clears a Bolder Surgical 510(k) for an expanded indication for the CoolSeal Trinity 5 mm Laparoscopic Vessel Sealer, Divider, and Dissector to inc...
FDA Review posts the Federal Register notices for the week ending 5/7/2021.
Federal Register notice: FDA announces that OMB has approved six information collections.
Federal Register notice: FDA seeks comments on an information collection extension entitled Medical Product Communications That Are Consistent With th...
Pfizer and BioNTech begin a rolling BLA to seek full approval of their mRNA vaccine to prevent Covid-19 in individuals 16 years of age and older.
Federal Register notice: FDA sends to OMB and information collection extension entitled Class 2 Special Controls Guidance Document: Labeling for Natur...
An FDA advisory committee splits on whether the efficacy data support approval for a ChemoCentryx NDA for avacopan targeting anti-neutrophil cytoplasm...