On June 17, the Food and Drug Administration announced the establishment of the Commissioner's National Priority Voucher (CNPV) program. Although initial details are sparse, the CNPV promises fast action, allowing drug...more
Last week, the U.S. Food and Drug Administration (FDA) issued two significant draft guidance documents concerning the use of artificial intelligence (AI) in medical devices and in drug and biological product development....more
1/16/2025
/ Artificial Intelligence ,
Bias ,
Biologics ,
Draft Guidance ,
Food and Drug Administration (FDA) ,
Life Sciences ,
Medical Devices ,
Premarket Approval Applications ,
Product Development Protocols ,
Regulatory Requirements ,
Risk Management ,
Software ,
Transparency
The U.S. Food and Drug Administration (FDA or the Agency) issued a Final Rule on May 6, 2024 (89 FR 37286), that will, over the next four years, radically alter the landscape for laboratory-developed tests (LDTs) and "correct...more
5/28/2024
/ Centers for Medicare & Medicaid Services (CMS) ,
CLIA ,
Clinical Laboratories ,
Diagnostic Tests ,
Enforcement ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Final Rules ,
Food and Drug Administration (FDA) ,
Laboratory Developed Tests ,
Medical Devices ,
Pharmaceutical Industry ,
Regulatory Requirements