Drug approvals, label changes, and FDA drug news.
This virtual training is designed to help staff at academic medical centers meet the federal requirements for registering clinical studies and reporting results on ClinicalTrials.gov.
These letters are supplied by the CDER Freedom of Information Office and only cover Office of Prescription Drug Promotion's untitled letters. FDA may have redacted or edited some of the letters to remove confidential information.
The Prescription Drug User Fee Act (PDUFA) was created by Congress in 1992 and authorizes FDA to collect fees from companies that produce certain human drug and biological products. Since the passage of PDUFA, user fees have played an important role in expediting the drug approval process.
The Food and Drug Administration (FDA) has approved changes to the Drugs Facts Label of the over-the-counter (OTC) weight loss drug, alli (orlistat) 60 mg capsules, to warn of risks of acute kidney injury, which is a rare side effect of the medication.
Compounding Quality Center of Excellence Virtual Conference
The Center of Excellence offers two discussion series - one for newly registered outsourcing facilities and one focused on quality, and we encourage outsourcing facilities and related stakeholders to get involved.
Compounded drugs can serve an important medical need for patients who cannot be treated with an FDA-approved drug, such as a patient who has an allergy and needs a drug to be made without a certain dye, or a child who cannot swallow a tablet or capsule and needs a medicine in a liquid dosage form.
The U.S. Food and Drug Administration (FDA), with the University of Maryland Center of Excellence in Regulatory Science and Innovation (M-CERSI), will host a workshop, “Accelerating Product Development for Pediatric Systemic Lupus Erythematosus” on July 30-31, 2026. This workshop will examine key similarities and differences between adult and pedia
On September 30, 2022, the President signed into law the FDA User Fee Reauthorization Act of 2022.
Compounded drugs are not FDA-approved. This means the agency does not verify their safety, effectiveness or quality before they are marketed. Learn more.
Quinacrine appears on the FDA 503B list of bulk drug substances that may be used in ccompounded drugs. FDA’s review for the 503B Bulks List determined that there is a clinical need for drug products compounded from quinacrine in the treatment of some patients with cutaneous lupus erythematosus.
Learn what HIV is and how CDER is working to prevent and treat HIV infections
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How you use sunscreens, and what other protective measures you take, make a difference in how well you are able to protect yourself and your family from sunburn, skin cancer, early skin aging and other risks of overexposure to the sun.
Today, the U.S. Food and Drug Administration added bemotrizinol to the list of permitted sunscreen active ingredients, marking a significant milestone in the agency's efforts to advance sunscreen innovation.
Information related to FDA’s preparation for the seventh reauthorization of PDUFA.
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