FDA Related News

Human Drugs

Study Finds Better Adverse Events Filed by Consumers

An new study suggests that FDAs 2013 move to a consumer-friendly adverse event reporting form has contributed positively to both the quality and quant...

Federal Register

Info Collection Extension for ANADAs

Federal Register notice: FDA submits to OMB an information collection extension for Abbreviated New Animal Drug Applications.

Human Drugs

FDA Required Post-Market Studies Empty Threat: Professor

Canadian health professor Matthew Herder says FDAs power to withdraw a drug if its manufacturer fails to produce useful required post-approval studies...

FDA Warns Umbilical Cord Blood Firm

FDA warns Stemell about multiple violations in its production of umbilical cord and umbilical cord blood products.

Federal Register

Review Period Determined for Bevyxxa

Federal Register notice: FDA determines the regulatory review period for patent extension purposes for Millennium Pharmaceuticals Bevyxxa (betrixaban ...

Human Drugs

CDERs Temple Covers Individualization in Drug Development

CDER deputy center director for clinical science Robert Temple discusses the move by industry and the agency to the third age of drug development the...

Medical Devices

Comments Extension for MRI-safe Device Guide

Federal Register notice: FDA extends the comment period for an 8/2 notice on a draft guidance on testing and labeling medical devices for MRI safety.

Human Drugs

CGMP Deviations at Chinas Yino, Inc.

FDA warns Chinas Yino, Inc., about significant CGMP deviations in its manufacturing of APIs.

Human Drugs

7 REMS Updates in July, August

FDA releases a summary of changes to seven REMS shown on the REMS Web site in July and August.

Federal Register

Guide on Uncertainty with Benefit-Risk Device Decisions

Federal Register notice: FDA releases final guidance entitled Consideration of Uncertainty in Making Benefit-Risk Determinations in Medical Device Pre...