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Federal Register

Latest Federal Register Notices

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

FDA General

Product Approval Summaries

FDA Review posts product approval summaries for the week ending 9/13/2021.

Federal Register

Allergenic Products Panel to Hear Research Overview

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

Human Drugs

Vor Biopharma Fast Track for AML Therapy

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

Federal Register

Comments Extended on Sunscreen Environmental Notice

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

OPDP Plans New Study on Disclosures in Advertising

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

Human Drugs

FDA Symposium on Trial Data Sharing

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

Medical Devices

FDA Inspecting Philips Respironics After Recall

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

Federal Register

Workshop on Opioid Prescriber Education Under REMS

Federal Register notice: FDA announces a public workshop entitled Reconsidering Mandatory Opioid Prescriber Education Through a Risk Evaluation and Mi...

Human Drugs

New FDA Jardiance Breakthrough Therapy Designation

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