FDA Related News

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.

Human Drugs

FDA Approved Expanded Verzenio Use

FDA approves Eli Lillys Verzenio (abemaciclib) in combination with an aromatase inhibitor as initial endocrine-based therapy for treating postmenopaus...

Federal Register

Advisory Panel to Review NDA on Opioid Withdrawal Drug

Federal Register notice: FDA announces a 3/27 Psychopharmacologic Drugs Advisory Committee meeting.

Federal Register

Public Meeting on Complex Clinical Trial Designs

Federal Register notice: FDA announces a 3/20 public meeting entitled Promoting the Use of Complex Innovative Designs in Clinical Trials.

Human Drugs

FDA Planning 2 Guidances on Opioid Addiction

FDA expects to release soon two new draft guidances intended to advance medication-assisted treatment for opioid addiction.

Biologics

FDA Probes Flu Vaccine Shortcomings

FDA commissioner Scott Gottlieb says the agency is investigating why this years flu vaccine was not very effective against one strain H3N2.

Human Drugs

Hospira Recalling 3 Labetalol Lots

FDA says Hospira has recalled three lots of labetalol hydrochloride due to cracks on vial rim surfaces.