Early Lyme Disease as Manifested by Erythema Migrans: Developing Drugs for Treatment

Biocon Sdn Bhd – 9/27/2024. Country: Malaysia. 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.

CGMP/Finished Pharmaceuticals/Adulterated

Medispray Laboratories Private Limited – 01/20/2025. Country: India. Record Type: 483

Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet

FDA and representatives of the generic drug industry meet quarterly to discuss topics related to the implementation of GDUFA.