Online Controlled Substances Summits
FDA hosted its fourth summit on June 8, 2023, as an integral part of FDA’s overall efforts to protect the public, including youth, from harm associated with drugs that have abuse potential.
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PAIN FLEX may be harmful due to hidden drug ingredients
The Food and Drug Administration is advising consumers not to purchase or use PAIN FLEX, a product promoted and sold for joint pain on various websites, including Amazon.com and possibly in some retail stores. -
Citalopram (marketed as Celexa) Information
Citalopram (marketed as Celexa) Information -
Approved Drugs: Questions and Answers
How is a medicine approved by FDA?, How can I find out if my medicine is approved by FDA? -
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.