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Federal Register

FDA Permanently Debars Duniel Tejeda

Federal Register notice: FDA permanently debars Duniel Tejeda from providing services in any capacity to a person that has an approved or pending drug...

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FDA General

$229 Million Boost in Senate FDA Budget Bill

The Senate Appropriations Committee posts its fiscal year 2023 proposed budget bill for FDA that increases the agencys spending by $229 million (7%), ...

Human Drugs

Accelerated Approval Program Largely Successful: Analysis

An Amgen study says the FDA accelerated approval program is working well and should not be changed because there are some drug outliers in the program...

Medical Devices

CDRH Still Working on AL/MI Guidance: Attorneys

Jones Day attorneys update FDAs commitments for a regulatory framework to address artificial intelligence as a tool for advancing medical therapeutics...

Medical Devices

bioMrieux Kidney Injury Assay Cleared

FDA clears a bioMrieux 510(k) for its Vidas Nephrocheck assay to detect kidney stress in patients at risk of acute kidney injury.

Biologics

Priority Review for Gamidas Omidubicel

FDA accepts for priority review a Gamida Cell BLA for omidubicel for treating patients with blood cancers in need of an allogenic hematopoietic stem c...

Human Drugs

FDA Publishes 48 Product-Specific Guidances

FDA publishes 48 new and revised product-specific guidances in its latest batch.

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Federal Register

FDA Withdrawing 7 No-Longer-Marketed ANDAs

Federal Register notice: FDA withdraws the approval of seven ANDAs from multiple applicants after they notified the agency that the drugs are no longe...

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Medical Devices

North American Diagnostics Recalls Covid Tests

North American Diagnostics recalls its Oral Rapid SARS-CoV-2 Rapid Antigen Test Kits because they were distributed without FDA authorization, clearanc...

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Human Drugs

Beam Hit With Clinical Hold on CAR-T Therapy

FDA issues a clinical hold on Beam Therapeutics BEAM-201 and its use in treating relapsed/refractory T-cell acute lymphoblastic leukemia/T cell lympho...