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FDA

Food and Drug Administration (FDA)

The Food and Drug Administration (FDA) is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation's food supply, cosmetics, and products that emit radiation. The FDA also provides accurate, science-based health information to the public.

This agency rolls up to Department of Health and Human Services (HHS).

0child agencies
2recorded aliases
2official source records

Agency profile

Core identity, hierarchy, and public contact details from the authoritative directory.

Official name
Food and Drug Administration
Display name
Food and Drug Administration (FDA)
Short name
FDA
Branch
Executive
Agency type
administration
Main address
10903 New Hampshire Ave. Silver Spring, MD 20993

Known names and aliases

Alternate names captured from the upstream authoritative sources.

Food and Drug Administrationofficial · primary
FDAshort name

Official links

Direct links back to government-maintained profiles and agency contact surfaces.

Official websiteContact pageUSA.gov profileU.S. Government Manual
Main address

10903 New Hampshire Ave. Silver Spring, MD 20993

Source records

Trace each directory field back to the official federal source that published it.

USA.gov
us_government_manual

Parent listing: Department of Health and Human Services

Hierarchy

This record sits inside a larger federal organization.

Parent agency

Department of Health and Human Services (HHS)

HHS

Recent rules and notices

Recent Federal Register items published by this agency. Read the summary here or jump to the raw public record.

Notice
Published October 26, 2026
91 FR 67321

Issuance of Priority Review Voucher; Rare Pediatric Disease Product; ISEMBYLD (apitegromab-mstn)

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 Federal Food, Drug, and Cosmetic Act (FD&C Act) authorizes FDA to award priority review vouchers to sponsors of approved rare pediatric disease product applications that meet certain criteria. FDA is required to publish notice of the award of the priority review voucher. FDA has determined that ISEMBYLD (apitegromab-mstn), approved September 11, 2026, manufactured by Scholar Rock, Inc., meets the criteria for a priority review voucher.

Read summaryOpen sourcePDF
Notice
Published October 23, 2026
91 FR 66848

Agency Information Collection Activities; Proposed Collection; Comment Request; Export Certificates for FDA Regulated Products

The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on export certificates for FDA regulated products.

Comment by December 22, 2026
Read summaryOpen sourcePDF
Notice
Published October 23, 2026
91 FR 66852

Agency Information Collection Activities; Proposed Collection; Comment Request; Product Jurisdiction and Combination Products

The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on information collection associated with product jurisdiction and combination product regulations.

Comment by December 22, 2026
Read summaryOpen sourcePDF
Notice
Published October 23, 2026
91 FR 66845

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Accreditation Scheme for Conformity Assessment Program

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) for review and clearance under the Paperwork Reduction Act of 1995.

Comment by November 23, 2026
Read summaryOpen sourcePDF
Notice
Published October 23, 2026
91 FR 66851

Determination of Regulatory Review Period for Purposes of Patent Extension; Correction of Notices-ANDEMBRY; ANZUPGO; ANKTIVA; BIZENGRI; BRINSUPRI; DAYVIGO

The Food and Drug Administration (FDA) is announcing corrections to the notices of Determination of Regulatory Review Period for Purposes of Patent Extension for ANDEMBRY; ANZUPGO; ANKTIVA; BIZENGRI; BRINSUPRI; and DAYVIGO. The original determinations were announced in the Federal Registers of August 10, 2026 (BRINSUPRI, DAYVIGO), August 17, 2026 (BIZENGRI), and September 9, 2026 (ANDEMBRY, ANZUPGO, ANKTIVA). Those notices correctly identified the dates on which the testing and approval phases began and ended but incorrectly stated the length of the regulatory review period due to calculation errors. No other changes are made.

Read summaryOpen sourcePDF
Notice
Published October 23, 2026
91 FR 66851

Questions and Answers Regarding Mandatory Cosmetics Recalls; Guidance for Industry; Availability

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled "Questions and Answers Regarding Mandatory Cosmetics Recalls: Guidance for Industry." The guidance document provides answers to common questions that might arise about FDA's mandatory recall authority for cosmetics. It is intended to inform regulated industry about the Agency's current thinking on implementation of certain aspects, including the criteria, process, and expectations, for mandatory recalls of cosmetic products. The guidance announced in this notice finalizes the draft guidance of the same title published on December 18, 2025.

Read summaryOpen sourcePDF

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