Approved Drugs: Questions and Answers
How is a medicine approved by FDA?, How can I find out if my medicine is approved by FDA?
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Overview of our role regulating and approving drugs | Video series
Learn how the FDA regulates drugs using science and data to ensure their safety, quality and efficacy. FDA plays a vital role in drug development and approval process. Watch our informative video series on FDA drugs, FDA approval, and the drug development process. -
Drug Safety Communications
FDA Drug Safety Communications connect consumers and health care professionals to important drug safety information. The webpage contains the most recent Drug Safety Communications from FDA as well as links for Early Communications, Follow-Up Early Communications, Information for Healthcare Professi -
Field Safety Notices: 18 to 22 August 2025
List of Field Safety Notices from 18 to 22 August 2025.
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AlzClipp / UniUni – 711274 – 07/29/2025
Unapproved New Drugs/Misbranded -
Breast implants – patient perception of risk research
Information for patients, public and healthcare professionals
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Cosmetic Breast Augmentation Risk Awareness Tool
New Cosmetic Breast Augmentation Risk Awareness Tool for patients to use when considering cosmetic breast implant surgery.
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List of Determinations Including Written Request
In accordance with section 505A(e)(1) of the Act, as amended by FDAAA (Pub. L. No. 110-85), the following list identifies those approved drugs for which a pediatric exclusivity determination was made, on or after September 27, 2007. -
Class 4 Medicines Defect Notification: Ipca Laboratories UK Limited, Various Products, EL(25)A/42
Ipca Laboratories UK Ltd has informed the MHRA that the Patient Information Leaflet (PIL) in the products listed in this notification do not contain all the required safety information.
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Viva Raw Issues Voluntary Recall of Two Lots of Dog an Cat Foods Due to Salmonella and Listeria Monocytogenes Contamination
August 25, 2025 – Viva Raw LLC, Charlotte, NC is voluntarily recalling two lots of dog and cat foods due to contamination with Salmonella and Listeria monocytogenes. The recall is for Lot 21495 (Viva Ground Beef for Dogs; Viva Beef & Turkey for Puppies) and Lot 21975 (Viva Ground Chicken for Dogs; -
Follow Instructions for Safe Use of Hyperbaric Oxygen Therapy Devices – Letter to Health Care Providers
The FDA is reminding the public about the safe use of hyperbaric oxygen therapy devices and is providing recommendations to help reduce potential risks. -
FDA Update on the Safety of Ixchiq (Chikungunya Vaccine, Live). FDA Suspends Biologics License: FDA Safety Communication
On August 22, 2025,the US FDA’s Center for Biologics Evaluation and Research has suspended the biologics license for Valneva Austria GmbH’s Ixchiq (Chikungunya Vaccine, Live). This vaccine was initially approved by FDA under the accelerated approval pathway in November of 2023 for the prevention of