CDER – Biological Product Deviations
CDER – Biological Product Deviations
La FDA advierte que los medios de contraste basados en gadolinio (MCBG) se depositan en el cuerpo y exige una nueva clase de advertencias
La FDA advierte que los medios de contraste basados en gadolinio (MCBG) se depositan en el cuerpo y exige una…
FDA Drug Safety Communication: FDA warns that gadolinium-based contrast agents (GBCAs) are retained in the body; requires new class warnings
FDA is requiring a new class warning and other safety measures for all gadolinium-based contrast agents (GBCAs) for magnetic resonance…
Products Approved for Anthrax
Discover FDA-approved products for anthrax preparedness and response. Get essential information on vaccines, treatments, and preventive measures to protect public…
FDA Drug Safety Communication: FDA revises description of mental health side effects of the stop-smoking medicines Chantix (varenicline) and Zyban (bupropion) to reflect clinical trial findings
An FDA review found the side effects on mood, behavior, or thinking with the stop-smoking medicines Chantix (varenicline) and Zyban…
Information by Drug Class
FDA provides consumers and industry with safety, regulatory and availability information for various drugs by drug class. From A to…
Frequently Asked Questions About Therapeutic Biological Products
Frequently Asked Questions About Therapeutic Biological Products
Drug Safety Oversight Board Meetings – Public Summaries
This page provides summaries of past DSB Meetings. Each summary include DSCs posted since the last meeting, topics presented and…
FDA Roundup: March 14, 2025
The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.
FDA Updates and Press Announcements on Angiotensin II Receptor Blocker (ARB) Recalls (Valsartan, Losartan, and Irbesartan)
Stay informed on FDA updates and press announcements about recalls involving angiotensin II receptor blockers (ARBs) like valsartan and losartan.…