153 updates found
The Food and Drug Administration (FDA or we) is proposing to require the submission of generally recognized as safe (GRAS) notices for the use of a human or an…
The Food and Drug Administration (FDA, Agency, or we) has determined that OZOBAX (baclofen) oral solution, 5 milligrams (mg)/5 milliliters (mL), was not withdr…
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for BRINSUPRI and is publishing this notice of that determinat…
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for DAYVIGO and is publishing this notice of that determinatio…
The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Molecular and Clinical Genetics Panel of the Medical De…
The Food and Drug Administration (FDA) is proposing to reclassify digital breast tomosynthesis (DBT) systems, product code OTE, which are postamendments class …
The Food and Drug Administration (FDA or Agency) is announcing the issuance of an Emergency Use Authorization (EUA) (the Authorization) under the Federal Food,…
The Food and Drug Administration (FDA) is classifying the fludeoxyglucose F18-guided radiation therapy system into class II (special controls). The special con…
The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a final guidance for industry (GFI) #152 entitled "Evaluating the Safet…
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) …
The Food and Drug Administration (FDA or we) received objections and requests for a public hearing submitted by Buchanan Ingersoll & Rooney PC, on behalf of Mi…
The Center for Drug Evaluation and Research (CDER) within the Food and Drug Administration (FDA or Agency), through its Quantitative Medicine Center of Excelle…
The Food and Drug Administration (FDA or the Agency) is reopening the comment period for the proposed rule that appeared in the Federal Register of May 6, 2026…
The Food and Drug Administration (FDA or the Agency) is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) permanently debarring Ricard…
The Food and Drug Administration (FDA or the Agency) is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) permanently debarring Angela…
The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a draft guidance for industry entitled "Biosimilar and Interchangeable …
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry titled "Assessing Adhesion With Transdermal an…
The Food and Drug Administration (FDA or Agency) is announcing the availability of a revised draft guidance for industry titled "Assessing the Irritation and S…
The Food and Drug Administration (FDA or we) is reopening the comment period for the notice titled "Butylated Hydroxytoluene (BHT); Request for Information," w…
The Food and Drug Administration (FDA, Agency, or we) is announcing the rates for biosimilar user fees for fiscal year (FY) 2027. The Federal Food, Drug, and C…
