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Allergenic Products Panel to Hear Research Overview

[ Price : $8.95]

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-...

FDA Symposium on Trial Data Sharing

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FDA announces a 9/23 symposium entitled FDA-PDS Symposium X Data Sharing; The Future of Clinical Trial Data SharingThe Art of the...

FDA Inspecting Philips Respironics After Recall

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FDA says it has initiated on-site inspections at Philips Respironics manufacturing facilities to assess compliance with regulatory...

Workshop on Opioid Prescriber Education Under REMS

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Federal Register notice: FDA announces a public workshop entitled Reconsidering Mandatory Opioid Prescriber Education Through a Ri...

Hahn is YourBio Health Interim Chief Medical Officer

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YourBio Health names former FDA commissioner Stephen Hahn as its interim chief medical officer.

New FDA Jardiance Breakthrough Therapy Designation

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FDA grants breakthrough therapy designation to Boehringer Ingelheim and Lillys Jardiance for treating heart failure with preserved...

Draft ICH Gene Therapy Guide

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Federal Register notice: FDA makes available a draft guidance entitled S12 Nonclinical Biodistribution Considerations for Gene Th...