U.S. Food and Drug Administration

FDA Commissioner Frank Young told a House subcommittee

then FDA commissioner David Kessler worked out an arrangement that met two industry demands

David Kessler, who ran the F.D.A. at the time, told me that he was “not involved in the approval.”

The F.D.A. examiner who oversaw the process, Dr. Curtis Wright, left the agency shortly afterward.

The F.D.A. approved OxyContin in 1995, for use in treating moderate to severe pain.

who stepped down from his role as the 23 rd Commissioner of the FDA earlier this year

Six years later she accepted an offer from the Food and Drug Administration to become one of just a handful of medical officers.

The drug was never marketed in the U. S.

Chang, former chief of ANDA Review Branch III

I am currently the Associate Director for Science and Medicine in FDA’s Office of Drug Safety.

Mr. Walter S. Kletch, a former review chemist in FDA's Division of Generic Drugs (public official)

issuing a final order under the Federal Food, Drug, and Cosmetic Act (the act) permanently debarring Mr. Walter S. Kletch

Chang Charles Y. 03/08/1993 Permanent^ 03/08/1993 58 FR 12967~

Isotretinoin can cause serious side effects, including birth defects. Because of the risk of severe birth defects, isotretinoin has only been available through a restricted distribution program called the iPLEDGE Program since 2005 and approved as the iPLEDGE REMS in 2010.

In 1988, hundreds of AIDS activists organized by the AIDS Coalition to Unleash Power (ACTUP) surrounded the FDA Parklawn headquarters building

pushed FDA to promulgate new accelerated approval regulations to accompany new treatment regulations for Investigational New Drugs implemented in 1987

FDA granted accelerated approval to Aduhelm on June 7, 2021

Certain products, including hand sanitizers, aerosols (spray), including antiperspirants and sunscreens, and benzoyl peroxide-containing acne treatment products have been recalled due to benzene contamination.

FDA recommends consumers use broad spectrum sunscreens with SPF values of at least 15, which have been shown to reduce the risk of skin cancer and early skin aging when used with other sun protection measures.

15 new tests from the same bottle of Johnson’s Baby Powder previously tested by the U.S. Food and Drug Administration (FDA) found no asbestos.

An ongoing investigation by CDC, state and local health departments, and the Food and Drug Administration is under way

Four years old and still going strong, a federal probe of the generic drug industry has left its mark

It has resulted in dozens of convictions, $20 million in fines

So far, seven drug companies, one laboratory and 29 individuals have been convicted on a variety of charges including giving and receiving illegal gifts, perjury and introducing drugs into the marketplace after submitting false testing data.

Federal prosecutors expect to close the investigation

An official website of the United States government

Although lenses must be impact resistant, it does not make the lenses shatterproof.

Conformance with the requirements of the following voluntary national or international standards, e.g., American National Standards Institute (ANSI), International Organization of Standards (ISO), is considered acceptable for good manufacturing practices

claims made by the manufacturer in the labeling for their sunglasses that claim they are constructed of lenses that block 100% UVA, UVB & UVC if such statements are untrue with respect to the sunglasses in question

FDA announced the withdrawal of the proposed rule titled “Testing Methods for Detecting and Identifying Asbestos in Talc-Containing Cosmetic Products,” which published in the Federal Register of December 27, 2024.

However, these studies have not conclusively demonstrated such a link, or if such a link existed, what risk factors might be involved.

FDA announced the withdrawal of the proposed rule titled "Testing Methods for Detecting and Identifying Asbestos in Talc-Containing Cosmetic Products,"

FDA is taking this action in response to comments received during the comment period for the proposed rule that warrant further consideration and assessment

On December 29, 2025, FDA published a report, entitled “Report on the Use of PFAS in Cosmetic Products and Associated Risks,”

The goals letter represents the product of FDA’s discussions with the regulated industry and public stakeholders, as mandated by Congress.

Historical Prescription Drug Activity Obligations by Funding Source

74% 76% 74% 78% 77%

PDUFA fees may be expended only for costs to support the “process for the review of human drug applications,”

The spending trigger was $287,573,564 for FY 2025, less than the $398,956,452 for non-user fee appropriations obligated for FY 2025, meaning the trigger was met.

FDA granted 23 waivers under 18 U.S.C. 208(b)(3) in FY 2023 (less than 3 percent of total meeting participants in attendance at meetings)

if the need for the individual's services outweighs the potential for a conflict of interest created by the financial interest involved.

This information is posted on FDA’s website prior to each meeting.

Reapply sunscreen at least every two hours, and more often if you're sweating or swimming.

SPF is not directly related to time of solar exposure but to amount of solar exposure.

To get the most protection out of sunscreen, choose a broad-spectrum sunscreen with an SPF of at least 15.

A sunscreen product’s SPF value is primarily an indicator of the level of protection that product provides against UVB radiation, but broad-spectrum sunscreens also protect against UVA radiation.

Use of the term "sunscreen" or similar sun protection wording in a product's labeling generally causes the product to be subject to regulation as a drug or a drug/cosmetic, depending on the claims.

There are no FDA-approved or legally marketed OTC skin lightening products.