FDA General
Bill Would Prevent Conflicting FDA Consultant Contracts
A Senate bill seeks to bar conflicts of interest in consulting contracts, such as those FDA signed with McKinsey & Co. on regulatory actions involving...
Federal Register
Latest Federal Register Notices
FDA Review posts the Federal Register notices for the week ending 3/25/2022.
FDA General
Since Our Last Issue ...
Industry news you may have missed since our last issue.
FDA General
Product Approval Summaries
FDA Review posts product approval summaries for the week ending 3/25/2022.
Federal Register
Drug User Fee Notice Correction
Federal Register notice: FDA corrects an 8/16/2021 notice entitled Prescription Drug User Fee Rates for Fiscal Year 2022.
Biologics
Review Extension Bristol-Myers sBLA for Reblozyl
Reblozyl is currently approved to address transfusion-dependent anemia-associated beta thalassemia and lower-risk myelodysplastic syndromes in patient...
Human Drugs
BMS Resolves Abraxane Drug Shortage
Bristol-Myers Squibb says it has resolved manufacturing constraints that led to global supply challenges for Abraxane for injectable suspension.
Medical Devices
AviClear Acne Laser Treatment Cleared
FDA clears a Cutera 510(k) for AviClear, a laser treatment for mild, moderate, and severe acne.
Human Drugs
FDA PI3K Concerns Hits MEI Pharmas Zandelisib
Ongoing FDA concerns about PI3K inhibitors prompts the agency to discourage MEI Pharma and Kyowa Kirin from seeking accelerated approved of a BLA for ...
Medical Devices
House Panel Grills FDA on Medtronic Heart Pump
The House Oversight and Reform committee asks FDA for answers to what regulatory enforcement actions it sought against Medtronics troubled HeartWare V...
