Today, the FDA took steps aimed at improving the quality, safety, and efficacy of sunscreens as part of its implementation of new authorities for certain over-the-counter (OTC) drugs.

FDA amended the emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 Vaccine to allow for the use of a single booster dose, to be administered at least six months after completion of the primary series with the Pfizer-BioNTech COVID-19 Vaccine in certain populations.

FDA releases profiles from a nonprofit organization on the current state of knowledge about medical device material performance after implantation.

FDA issues two draft guidance documents focused on donor eligibility and current good manufacturing practices for manufacturers of animal cells, tissues, and cell- and tissue-based products that, if finalized, may help support the development of promising and innovative products that can benefit ani

FDA authorizes software to assist pathologists detect areas that are suspicious for cancer as an adjunct to the standard of care review of digitally-scanned slide images from prostate biopsies.

FDA Approves First Biosimilar to Treat Macular Degeneration Disease and Other Eye Conditions

Today, the FDA posted an initial batch of four deemed final administrative orders as part of the Over-the-Counter Monograph Reform under the Coronavirus Aid, Relief, and Economic Security Act

Coronavirus (COVID-19) Update: September 17, 2021

A Federal court has entered a consent decree against a Florida compounder, prohibiting the manufacture and distribution of drugs due to insanitary conditions

The U.S. Food and Drug Administration hosted its third Online Opioid Summit, “Reducing the Availability of Opioids Online,” as part of the agency’s efforts to address the illegal availability of opioids online.

The FDA announces reorganization of the information technology, data and cybersecurity offices into the agency-level Office of Digital Transformation and Vid Desai as the agency’s Chief Information Officer.

FDA announces winners of New Era of Smarter Food Safety Low- or No-Cost Tech-enabled Traceability Challenge

Coronavirus (COVID-19) Update: September 10, 2021

FDA leadership outlines steps the FDA will take to ensure the safety and efficacy of COVID-19 vaccines for young children

FDA made significant progress since Sept, 9, 2020, working diligently to better understand these ENDS products and have taken action on about 93% of the total timely-submitted applications.

Today, the FDA and FTC posted warning letters to 10 companies for selling dietary supplements claiming to treat diabetes

The FDA will meet with members of the food industry, regulatory counterparts at all levels of government, consumers, and others to enhance our understanding of how human and animal foods are sold through e-commerce business models.

The FDA announces a two-day public workshop to give stakeholders an opportunity to provide input on aspects of the current opioid crisis that could be mitigated in a measurable way by requiring mandatory prescriber education as part of a REMS.

Coronavirus (COVID-19) Update: September 7, 2021

FDA In Brief: FDA Reaches Milestone in Competitive Generic Therapy Drug Approvals, Marking Success of Program that Encourages Development of Drugs with Inadequate Generic Competition