Drugs

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FDA approves drug for sickle cell anemia

Nov 25 - Reduces effect of red blood cell sickling in patients 12 and older

FDA announces launch of CURE ID app for clinicians

Dec 6 - For reporting new uses of existing drugs to treat infectious diseases

FDA approves drug for Duchenne Muscular Dystrophy

Dec 12 - For pediatric and adult patients with a particular mutation

Drug Information, Safety, and Availability

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Drug Development and Review Process

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About the Center for Drug Evaluation and Research (CDER)

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Consumers and Patients

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Health Care Professionals

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Industry

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Opioids

Reducing the impact of opioid misuse and abuse

Generics

Ensuring access to safe, affordable, and effective generic drugs

Warning Letters

Warning and Notice of Violation Letters to Pharmaceutical Companies

Guidances

FDA's current thinking on drug development and review activities

Drug Development Tools Qualification Program

Using scientific and technical innovations for better drug development

21st Century Cures at CDER

Bringing innovative and advanced medicines to patients faster

Expanded Access | Compassionate Use

Providing access to investigational drugs outside of clinical trials

Drug Shortages

Search the database, learn about root causes and potential solutions

Dec 04

FDA Updates and Press Announcements on NDMA in Zantac (ranitidine)

Nov 07

FDA Updates and Press Announcements on Angiotensin II Receptor Blocker (ARB) Recalls (Valsartan, Losartan, and Irbesartan)

Nov 01

Questions and Answers: NDMA impurities in ranitidine (commonly known as Zantac)

Drug Safety Announcements

Center

Nov 19

Precision Dose Inc. Issues Voluntary Nationwide Recall of Ranitidine Oral Solution, USP 150 mg/10 mL Due to Possible Presence of N-nitrosodimethylamine (NDMA) Impurity

Nov 15

Golden State Medical Supply, Inc. Issues a Voluntary Nationwide Recall of Ranitidine Hydrochloride 150mg and 300mg Capsules (Manufactured by Novitium Pharma LLC) Due to an Elevated Amount of Unexpected Impurity, N-Nitrosodimethylamine (NDMA)

Nov 13

Nature’s Rx Issues Voluntary Nationwide Recall of Silver Bullet 10 Male Enhancement Capsules Due to an Undeclared PDE-5 Inhibitor Found in the Product

Center

Dec 12

FDA grants accelerated approval to first targeted treatment for rare Duchenne muscular dystrophy mutation

Dec 11

FDA issues warning letter for not including the most serious risks in advertisement for medication-assisted treatment drug

More Press Announcements

CENTER FOR DRUG EVALUATION AND RESEARCH

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CDER Division of Drug Information

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