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Federal Register

Device Rule Reduces Paper Copy Submissions

Federal Register final rule: FDA amends the medical device regulations to update mailing address information and to reduce the number of copies of cer...

Federal Register

Animal Drug Regs Amended for Approvals

Federal Register final rule: FDA amends the animal drug regulations to reflect application-related actions for new animal drug applications and abbrev...

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...

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...