administrator

Har Maspeth Corp Issues Allergy Alert on Undeclared Eggs in “Jinga Glass Noodles w/ Vegetables (Japche)”

HAR Maspeth Corp, Maspeth NY, is recalling its 8 ounce and 12 ounce packages of “JINGA GLASS NOODLES W/ VEGETABLES…

C.H. Guenther & Son LLC Issues Allergy Alert on Undeclared Egg in “365 Whole Foods Market Small Bites Macaroni & Cheese”

C.H. Guenther & Son LLC of San Antonio, TX, is recalling its 365 Whole Foods Market Small Bites Macaroni &…

UPS to cut sorting shift in Charlotte as more closures loom

The carrier is evaluating further reductions in its network as part of an efficiency push, but details are limited.

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…

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…