153 updates found
The Food and Drug Administration (FDA or Agency) is announcing the availability on its website of the final administrative order (final order) (OTC000008-1) ti…
The Food and Drug Administration (FDA, Agency, or we) is announcing an opportunity for public comment on the proposed collection of certain information by the …
The Food and Drug Administration (FDA or the Agency) is announcing that a proposed collection of information has been submitted to the Office of Management and…
The Food and Drug Administration (FDA) is classifying the cardiovascular machine learning-based notification software into class II (special controls). The spe…
The Food and Drug Administration (FDA or we) is announcing the withdrawal, without prejudice to a future filing, of a food additive petition (FAP 2323) proposi…
The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a guidance for industry titled "Temporary Policies for Compounding Cert…
The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Vaccines and Related Biological Products Advisory Commi…
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) has determined the regulatory review period for ANDEMBRY and is publishing this notice of that determinati…
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) has determined the regulatory review period for ANZUPGO and is publishing this notice of that determinatio…
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for ANKTIVA and is publishing this notice of that determinatio…
The Food and Drug Administration (FDA or Agency) is opening a public docket to solicit comments on FDA's efforts to advance development of botanical drug produ…
The Food and Drug Administration (FDA or Agency) has determined that PHENAPHEN WITH CODEINE NO. 3 (acetaminophen; codeine phosphate) oral capsules, 325 milligr…
The Food and Drug Administration (FDA, Agency, or we) has determined that CARAFATE (sucralfate) oral suspension, 1 gram (g)/10 milliliters (mL), was not withdr…
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry titled "Pharmacokinetics in Patients with Impaired Hepat…
The Food and Drug Administration (FDA or Agency) is announcing the availability of two final guidances titled "Dental Composite Resin Devices--Premarket Notifi…
The Food and Drug Administration (FDA) is announcing the issuance of a priority review voucher to the sponsor of a rare pediatric disease product application. …
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry (GFI) #116 (VICH GL23(R2)) titled "Studies to …
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry (GFI) #115 (VICH GL22(R)) titled "Studies to E…
