A key element of the U.S. Food and Drug Administration’s mission is focused on helping to ensure that all products we regulate, including drugs available to consumers, are safe and of high quality.
The use of dietary supplements, such as vitamins, minerals or herbs, has become a routine part of the American lifestyle.
At the FDA, protecting patient and consumer health is our highest priority.
Advances in technology and material science are enabling new opportunities to transform health and mobility through innovations in medical products.
On Thursday, March 14, 2019, the FDA will host a webinar on the final guidance entitled, "The Least Burdensome Provisions: Concept and Principles."
On Tuesday, March 19, 2019, the FDA will host a webinar to share information and answer questions regarding the implementation of the final rule on “Human Subject Protection; Acceptance of Data From Clinical Investigations for Medical Devices.”
The Forum will focus on the latest trends and enhancements in laser-based imaging modalities such as Optical Coherence Tomography (OCT) and Adaptive Optics (AO), regulatory and reimbursement considerations, and new topics of interest such as the Medical Device Development Tool Program and the emerging role of Artificial Intelligence.
An audio podcast series featuring the Director of FDA Center for Drug Evaluation and Research
Drug shortages have a significant impact on both hospitals and patients.
For two decades, CDER has used certain methods to speed drug development and the regulatory review process so that promising therapies can get to patients faster.
Safety concerns have led to a government warning about a wearable defibrillator.
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FDA is warning of the possibility of a shortage of sterilized medical devices, possibly posing a threat to public health.
The U.S. Department of Agriculture’s (USDA) Food Safety and Inspection Service (FSIS) and the U.S. Department of Health and Human Services’ (HHS) Food and Drug Administration (FDA) today announced a formal agreement to jointly oversee the production of human food products derived from the cells of livestock and poultry.
The U.S. Food and Drug Administration today approved a new indication for a heart valve repair device that is intended to reduce moderate-to-severe or severe mitral regurgitation, a leakage of blood backward through the mitral valve into the heart’s left atrium that can cause heart failure symptoms such as shortness of breath, fatigue and swelling in the legs.
The U.S. Food and Drug Administration allowed marketing of a new device, ClearMate, intended to be used in an emergency room setting to help treat patients suffering from carbon monoxide poisoning.
The Food and Drug Administration (FDA) is acknowledging a rise in medical device reports concerning surgical staples and staplers used internally.
Former Food and Drug Administration (FDA) Commissioner Scott Gottlieb released a statement last week on the importance of naming biological medicines that will benefit by having a lower cost to patients.
Pharmaceutics International, Inc. (Pii), a Contract Development and Manufacturing Organization (CDMO) headquartered in Hunt Valley, Maryland, is pleased to announce the launch of Busulfan Injection, 6mg/mL in 10mL vials, in partnership with Athenex Pharmaceuticals, Sungen Pharma and Chemwerth.
Label Now Includes New Data on Use of AVYCAZ for Treatment of cUTI and cIAI in Pediatric Patients 3 Months of Age and Older
Boehringer Ingelheim has filed for regulatory approval of nintedanib in patients with systemic sclerosis associated interstitial lung disease (SSc-ILD) with the FDA and EMA.