FDA Related News

Federal Register

11 Covid-19 Product EUAs Revoked

Federal Register notice: FDA announces the revocation of 11 Covid-related Emergency Use Authorizations after the authorization holders requested they ...

Federal Register

Stimulant Use Disorder Drug Development Guide

Federal Register notice: FDA releases a draft guidance entitled Stimulant Use Disorders: Developing Drugs for Treatment.

Human Drugs

FDA Looking Into Counterfeit Ozempic: Report

CBS News says a drug supply chain association issued an alert that FDA is investigating counterfeit Ozempic.

Human Drugs

NextGen Portal Accepts OTC Monograph Files

CDER says its NextGen Portal is now accepting Over-the-Counter Monograph Order Requests.

Biologics

Coherus Refiles Udenyca Onbody BLA Supplement

Coherus BioSciences resubmits a BLA supplement for Udenyca Onbody, the company's on-body injector presentation of Udenyca (pegfilgrastim-cbqv), a bios...

Human Drugs

Panel Votes Down Amgens Confirmatory Study

FDAs Oncologic Drugs Advisory Committee votes 10 to 2 that the CodeBreak 200 confirmatory study cannot be reliably interpreted as the basis for Amgens...

Human Drugs

AstraZeneca Comments on FDA QTc Draft Guidance

AstraZeneca suggests several things FDA could add to a draft guidance on QTc information in drug and biologic labeling.

Reagan-Udall Strategies to Understand Regulated Products

The Reagan-Udall Foundation publishes a report with strategies for FDA to consider to improve public understanding of FDA and its regulated products.

Medical Devices

FDA Unsatisfied with Philips Respironics Recall

CDRH director Jeffrey Shuren says FDA believes there is more Philips Respironics needs to do as part of its recall of ventilators and BiPAP and CPAP m...

Human Drugs

Stimulant Use Disorder Treatment Guidance

FDA publishes a draft guidance to assist sponsors in developing drugs and biologics to treat stimulant use disorders.