FDA announces a 6/10 Vaccines and Related Biological Products Advisory Committee meeting to discuss Covid-19 vaccines and their use in the pediatric p...
The Multidisciplinary Association for Psychedelic Studies asks FDA to remove a clinical hold against a study designed to assess the psychological effe...
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...