FDA Drug Competition Action Plan | Improving the efficiency of the generic drug development, review, and approval process

This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program

FDA’s CDER Small Business and Industry Assistance (SBIA) is making available our YouTube learning library – now hundreds of our recordings are readily accessible.

CGMP/Finished Pharmaceuticals/Adulterated

Fukuzyu Pharmaceutical Co., Ltd. – 1/19/2024. Country: Japan. Record Type: 483

This listing includes accelerated approvals (AAs) for malignant hematology and oncology indications that have postmarketing requirement(s) for ongoing clinical trial(s) to verify clinical benefit.

Gina Marie Bakery of Waterbury, CT is recalling 1lb and 2 lb packages of the above-mentioned cookies because they contain undeclared allergens. People who have allergies to nuts, sesame seeds and/or food dyes run the risk of serious or life-threatening allergic reaction if they consume these produc