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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.

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 April 13, 2026

91 FR 18866

Determination That BILTRICIDE (Praziquantel) Oral Tablet, 600 Milligrams, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness

The Food and Drug Administration (FDA or Agency) has determined that BILTRICIDE (praziquantel) oral tablet, 600 milligrams (mg), was not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to this drug product, and it will allow FDA to continue to approve ANDAs that refer to the product as long as they meet relevant legal and regulatory requirements.

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Official links

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Official website Contact page USA.gov profile U.S. Government Manual

Main address

10903 New Hampshire Ave. Silver Spring, MD 20993

Source records

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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

Notice

Published April 10, 2026

91 FR 18464

Agency Information Collection Activities; Proposed Collection; Comment Request; Color Additive Certification

Comment by June 9, 2026

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Notice

Published April 10, 2026

91 FR 18466

Agency Information Collection Activities; Proposed Collection; Comment Request; Submission of Petitions: Food Additive, Color Additive (Including Labeling), Submission of Information to a Master File in Support of Petitions; and Electronic Submission Using Food and Drug Administration Form 3503

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 the information collection provisions of FDA's regulations for submission of petitions, including food and color additive petitions (including labeling), submission of information to a master file in support of petitions, and electronic submission using Form FDA 3503.

Comment by June 9, 2026

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Notice

Published April 10, 2026

91 FR 18472

GlaxoSmithKline; Withdrawal of Approval of a New Drug Application for Wellcovorin (Leucovorin Calcium) Tablets, EQ 5 mg Base and EQ 25 mg Base

The Food and Drug Administration (FDA or Agency) is withdrawing approval of a new drug application (NDA) for Wellcovorin (leucovorin calcium) tablets, EQ 5 mg base and EQ 25 mg base, held by GlaxoSmithKline, LLC, 2020 Walnut Street, Philadelphia, PA 19104 (GSK). GSK notified the Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.

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Notice

Published April 10, 2026

91 FR 18468

Agency Information Collection Activities; Proposed Collection; Comment Request; Premarket Approval of Medical Devices

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 premarket approval of medical devices.

Comment by June 9, 2026

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Notice

Published April 7, 2026

91 FR 17660

Issuance of Priority Review Voucher; Rare Pediatric Disease Product; LOARGYS (pegzilarginase-nbln)

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 LOARGYS (pegzilarginase-nbln), approved February 23, 2026, manufactured by Immedica Pharma AB, meets the criteria for a priority review voucher.

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