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Class 1 Recall of Ultrasound Gels

[ Price : $8.95]

FDA classifies as Class 1 an Eco-Med Pharmaceutical recall of all ultrasound gels and lotions manufactured by the company (XXX SUB...

BeiGen BLA for Anti-PD-1 Tislelizumab

[ Price : $8.95]

FDA accepts for review a BeiGene BLA for its anti-PD-1 antibody tislelizumab as a treatment for patients with unresectable recurre...

3 NDAs Withdrawn Over Missed Annual Reports

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Federal Register notice: FDA withdraws three NDAs because the application holders have repeatedly failed to file required annual r...

Retiring Vaccine Officials Reluctant on Boosters

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A Lancet article authored by two retiring senior FDA vaccine officials and other researchers argues against requiring Covid-19 boo...

Blood Products Panel to Hear Lab Research Updates

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Federal Register notice: FDA announces an 11/4 Blood Products Advisory Committee meeting that will hear CBER research updates.

Latest Federal Register Notices

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FDA Review posts the Federal Register notices for the week ending 9/10/2021.

Allergenic Products Panel to Hear Research Overview

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Federal Register notice: FDA announces a 10/28 Allergenic Products Advisory Committee meeting that will hear an overview of certai...

Vor Biopharma Fast Track for AML Therapy

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FDA grants Vor Biopharma a fast track designation for VOR33, Vors engineered hematopoietic stem cell therapeutic candidate for tre...

Comments Extended on Sunscreen Environmental Notice

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Federal Register notice: FDA reopens the comment period for public scoping on the environmental impact statement described in the ...

OPDP Plans New Study on Disclosures in Advertising

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CDERs Office of Prescription Drug Promotion proposes to examine whether disclosures in direct-to-consumer and healthcare provider-...