Accolade Pacemaker Devices by Boston Scientific and Potential Need for Early Device Replacement – FDA Safety Communication

Approved active drugs with sponsors to which FDA has granted exclusivity for pediatric studies under Section 505A of the Federal Food, Drug, and Cosmetic Act (FD&C Act)

Immacule Lifesciences Private Limited – 09/18/2025. Country: India. Record Type: 483

CGMP/Finished Pharmaceuticals/Adulterated

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

Lupin Limited Unit 2 – 7/17/2025. Country: India. Record Type: 483

FDA removes risk evaluation and mitigation strategy (REMS) program for the antipsychotic drug Clozapine