Federal Register notice: FDA makes available an annual compilation of updates to the agencys Susceptibility Test Interpretive Criteria Web page.
Reuters says FDA is ready to authorize AstraZeneca to resume its U.S. trial of a Covid-19 vaccine that has been on hold since 9/6 due to a trial parti...
FDA awards a $1.1 million contract to EpiVax and CUBRC to continue its work on evaluating generic peptide drugs and their impurities.
FDA issues a compliance policy guidance delaying for three additional years enforcement of a provision for wholesale distributors to verify the produc...
Politico reports, based on anonymous sources, that HHS secretary Alex Azar is opening plotting to remove FDA commissioner Stephen Hahn from his post.
An FDA final guidance delays the enforcement of certain Drug Supply Chain Security Act requirements.
Federal Register notice: FDA announces that it intends to conduct a fit-for-use pilot program to test the processing and analysis of nonclinical study...
FDA approves Avioqs VioOne HIV Profile Supplemental Assay, an enzyme-linked immunosorbent assay for confirmation and differentiation of individual ant...