FDA General
Senator Scott Urges FDA to Fill Vacancies
Senator Rick Scott (R-FL) urges FDA to fill vacant management posts at CDER and CBER because FDA is too important an agency to operate under temporary...
FDA General
FDA Budget Request Seeks $2.1 Billion Spending Boost
FDA outlines a $2.1 billion (34%) boost in its fiscal year (FY) 2023 proposed spending plan as part of president Bidens just-released budget request, ...
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...
Medical Devices
Staar Surgical Implantable Vision Correction Lens OKd
FDA approves a Staar Surgical PMA for the EVO/EVO+ Visian Implantable Collamer Lens for correcting myopia and myopia with astigmatism.
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.
