FDA Related News

Federal Register

Correction: FDA Says Baxter Clinolipid NDA Not Withdrawn

Federal Register notice: FDA corrects a 6/21/2017 Federal Register notice that incorrectly announced the withdrawal of a Baxter Healthcare NDA for Cli...

Federal Register

Workshop on Tissue Agnostic Therapies

Federal Register notice: FDA announces a 5/9 public workshop on Tissue Agnostic Therapies in Oncology: Regulatory Considerations for Orphan Drug Desig...

Human Drugs

CGMP Violations in Shanghai Weierya Inspection

FDA warns Chinas Shanghai Weierya about CGMP regulation violations in its production of finished pharmaceuticals as a contract manufacturer.

FDA General

Issues Seen in Regulatory Accountability Act

Healthcare and legal researchers say the proposed Regulatory Accountability Act could have negative impacts on FDA and other agencies working to impro...

FDA General

Latest FDA Warning Letters

FDA releases its latest batch of Warning Letters that includes Alchymars ICM SM Private Ltd., Nowcos Co., Ltd. and Shanghai Weierya Daily Chemicals Fa...

Human Drugs

Akorn Investigating Data Integrity Issues

Akorn says it is investigating alleged breaches of FDA data integrity requirements.

Medical Devices

FDA Clears Expanded Use for Acclarent Inner Ear Device

FDA clears an Acclarent 510(k) to expand the indication for the Acclarent Aera Eustachian Tube Balloon Dilation System to include its use in patients ...

Human Drugs

FDA Accepts NDA for Tetraphase Pharmaceuticals Antibiotic

FDA accepts for review a Tetraphase Pharmaceuticals NDA for eravacycline for treating complicated intra-abdominal infections.

Human Drugs

Synergy Wants Linzess Labeling Changed

Synergy says FDA should require Forest to change the way it reports Lizess adverse event information in the drugs labeling.

FDA Moves to Expedite Rare Disease Products

FDA commissioner Scott Gottlieb says the agency is taking steps to increase development of products to address rare diseases.