153 updates found
The Food and Drug Administration (FDA or the Agency) is announcing the issuance of three Emergency Use Authorizations (EUA or Authorization) under the Federal …
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 Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agenc…
The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agenc…
The Food and Drug Administration (FDA or Agency) is denying a request for a hearing submitted by Rahim Shafa (Dr. Shafa) and is issuing an order under the Fede…
The Food and Drug Administration (FDA or Agency) is extending the effective date of the notice published in the Federal Register on May 27, 2026, entitled "Dru…
The Food and Drug Administration (FDA, Agency, or we) has determined that CABAZITAXEL (cabazitaxel) solution (injection), 60 milligrams (mg)/6 milliliters (mL)…
The Food and Drug Administration (FDA or Agency) is providing interested persons with the opportunity to submit comments concerning abuse potential, actual abu…
The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agenc…
The Food and Drug Administration (FDA or the Agency) is announcing a publication containing modifications the Agency is making to the list of standards FDA rec…
The Food and Drug Administration (FDA or Agency) is announcing the availability of additional draft and revised draft product-specific guidances. The draft gui…
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry titled "Evaluation of Therapeutic Equivalence.…
The Food and Drug Administration (FDA) is announcing the renewal of the Oncologic Drugs Advisory Committee by the Commissioner of Food and Drugs (the Commissio…
The Food and Drug Administration (FDA) is announcing the renewal of the Cardiovascular and Renal Drugs Advisory Committee by the Commissioner of Food and Drugs…
The Food and Drug Administration (FDA) is announcing the renewal of the Endocrinologic and Metabolic Drugs Advisory Committee by the Commissioner of Food and D…
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft document titled "Potency Assessment of Active Immunotherapy Products…
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance titled "Frequently asked Questions--Developing Potential Ce…
The Food and Drug Administration (FDA or we) is announcing that we have filed a petition, submitted by Gardenia Blue Interest Group (GBIG or petitioner), c/o E…
The Food and Drug Administration (FDA or we) is announcing that we have filed a petition, submitted by the International Association of Color Manufacturers, pr…
The Food and Drug Administration (FDA, we, or the Agency) is amending the regulations for food additives permitted in feed and drinking water of animals to pro…