FDA Related News

Human Drugs

Warren Introduces Government Drug Manufacturing Bill

Sen. Elizabeth Warren introduces legislation to authorize the federal government to manufacture some generic drugs and sell them to the public.

Human Drugs

Aurobindo Recalls Lots with NDEA Contamination

FDA says Aurobindo Pharma has recalled lots of three drugs containing valsartan with levels of NDEA above the interim daily acceptable intake level.

Medical Devices

Medical Device Review Process Progress in Place: Report

Booz Allen says FDA has done well in implementing recommendations to improve its medical device review process.

FDA Strengthening Essure Post-Marketing Study

FDA commissioner Scott Gottlieb says the agency is requiring Bayer to take steps to strengthen its study of Essure patients following removal of the p...

FDA General

FDA Faces Challenges in U.S. Government Shutdown

The new year brings ongoing challenges for FDA, 60% of whose employees are now working without pay because of the partial government shutdown, and the...

Human Drugs

FDA Approves Alexions Ultomiris

FDA approves Alexions Ultomiris to treat paroxysmal hemoglobinuria in adult patients.

Human Drugs

Torrent Recalls 2 Lots of Losartan Due to NDEA

FDA says Torrent has recalled two lots of losartan potassium 100 mg tablets due to the presence of NDEA.

Biologics

Multiple Violations at Genetech Umbilical Cord Blood Facility

FDA warns Genetech about many violations involving its processing of human umbilical cord blood derived cellular products distributed to Liveyon LLC f...

Medical Devices

FDA Draft Guide on X-ray Equipment Regs

FDA posts a draft guidance entitled Clarification of Radiation Control Regulations For Manufacturers of Diagnostic X-Ray Equipment.

Federal Register

Proposed Rule on Drug Labeling Changes Withdrawn

Federal Register proposed rule withdrawal: FDA announces the withdrawal of a proposed rule on Supplemental Applications Proposing Labeling Changes for...