Understanding the Risks of Compounded Drugs
Compounded drugs are not FDA-approved. This means the agency does not verify their safety, effectiveness or quality before they are marketed.Compounded drugs can serve an important medical need for patients. However, if a compounded drug does not meet appropriate...Compounding and the FDA: Q & A
Why do some patients need compounded drugs?A drug may be compounded for a patient who cannot be treated with an FDA-approved medication, such as a patient who has an allergy to a certain dye and needs a medication to be made without it, or an elderly patient or a...OTC Monograph Reform: OTC Sunscreen Drugs
On This Page Date: December 15, 2021 Time: 3:00 p.m. – 4:00 p.m. ET Visit CDER Small Business and Industry Assistance PageABOUT THIS WEBINAROn September 24, 2021, FDA took steps aimed at improving the quality, safety, and efficacy of sunscreens as part of its...Sunscreen Innovation Act (SIA)
On March 27, 2020, the Coronavirus Aid, Relief, and Economic Security Act (CARES Act) (Public Law No. 116-136, 134 Stat. 281, 457) was signed into law. Section 505G of the CARES Act reforms and modernizes the OTC drug review process. It also includes provisions that...Office of Prescription Drug Promotion (OPDP) News
The Brief SummaryThe Brief Summary is a quarterly bulletin intended for all OPDP stakeholders. Started in January 2022, The Brief Summary provides news and updates related to OPDP. Subscribe to The Brief Summary here and join the “Prescription Drug...Do Not Use Unauthorized Infant Devices for Monitoring Vital Signs
Date Issued: September 16, 2025The U.S. Food and Drug Administration (FDA) is warning consumers, caregivers, and health care providers of risks related to using unauthorized infant monitors for measuring and monitoring vital signs (such as heart or pulse rate, oxygen...Guidance for Industry
Docket Number: FDA-2025-D-0346 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a draft guidance for industry entitled “Erosive Esophagitis: Developing...Do Not Use Unauthorized Devices for Measuring Blood Pressure: FDA Safe
Date Issued: September 16, 2025The U.S. Food and Drug Administration (FDA) is warning consumers, patients, caregivers, and health care providers of risks related to using unauthorized devices that claim to measure or estimate blood pressure. Many blood pressure...Click To Verify Security & Validation
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