Federal Register notice: FDA makes available a draft guidance entitled Adjusting for Covariates in Randomized Clinical Trials for Drugs and Biologics ...
Federal Register notice: FDA makes available a final guidance entitled Extending Expiration Dates of Doxycycline Tablets and Capsules in Strategic Sto...
FDA issues a guidance to help government stakeholders know if they can extend the expiration date of stockpiled doxycycline, confident that it has ret...
FDA releases a draft guidance on adjusting for covariates in clinical trials for drugs and biologics with continuous outcomes.
Federal Register notice: FDA makes available a draft guidance entitled Initiation of Voluntary Recalls Under 21 CFR part 7, subpart C.
Federal Register notice: FDA announces a 5/30-31 Advisory Committee meeting to discuss reclassification proposals for surgical stapler devices and cer...
Federal Register notice: FDA makes available an update to the immediately in effect guidance entitled Compliance Policy for Combination Product Postma...
FDA grants Orchestra BioMed a breakthrough device designation for its Virtue Sirolimus-eluting Balloon for treating coronary in-stent restenosis.