by Ismail Amin | Jul 25, 2022 | Biotech Bulletin, News
FDA guidance regarding consumer health products and the enforcement of Global Unique Device Identification Database submission requirements. In its July 25, 2022, guidance document – The FDA (by and through the Center for Biologics Evaluation and Research and...
by Ismail Amin | Jul 25, 2022 | Biotech Bulletin, News
FDA issues guidance and recommendations for New Drug Applications (NDA) and Biologic Laboratory Applications (BLA) which implicate oncology therapies and warrant Real time Oncology Review (RTOR). On July 25, 2022, the FDA, by and through the Oncology Center for...
