FDA Related News

Human Drugs

Acceptable ARB Nitrosamine Impurity Levels

FDA posts interim acceptable levels of nitrosamine impurities in angiotensin II receptor blockers.

Human Drugs

FDA Approves Herzuma, Biosimilar Herceptin

FDA approves Celltrions Herzuma, a biosimilar breast cancer drug for Genentechs Herceptin.

Human Drugs

FDA Finalizes Cancer Trial Endpoints Guidance

FDA finalizes a 2007 guidance on endpoints for drug and biologic cancer trials.

Human Drugs

FDA Approves Stemlines Elzonris for Rare Blood Disease

FDA approves Stemline Therapeutics Elzonris for treating blastic plasmacytoid dendritic cell neoplasm.

Pull Ad Drug Price Disclosure Proposal: WLF

Washington Legal Foundation says CMS should withdraw its proposal to require drug companies to include pricing information in DTC television ads becau...

Animal Drugs

Sales of Food Animal Antimicrobial Drugs Down: Gottlieb

FDA commissioner Scott Gottlieb says the agencys 2017 report on antimicrobial sales/distribution for use in food animals shows that efforts to signifi...

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...