FDA Webview
X
about-us-banner

FDA Related News

Home / Articles / FDA Related News
Human Drugs

Immunotoxic Potential Draft Guidance Out

FDA publishes a draft guidance to help sponsors of some products regulated by CDER and CBER perform nonclinical safety evaluations of the products imm...

Human Drugs

Ex-FDA Lawyer McConagha Moves to Skadden

Former FDA attorney William McConagha moves from Sidley Austin to Skadden, Arps, Slate, Meagher & Flom as health care litigation and enforcement pract...

Federal Register

Panel to Review Glaxo Trelegy Ellipta sNDA

Federal Register notice: FDA announces a 4/21 Pulmonary-Allergy Drugs Advisory Committee meeting to discuss a GlaxoSmithKline supplemental NDA for Tre...

Federal Register

Medical Imaging Panel to Review Alzheimers Diagnostic

Federal Register notice: FDA announces a 4/23 Medical Imaging Drugs Advisory Committee meeting to review an Avid Radiopharmaceuticals NDA for a radioa...

Human Drugs

FDA Denies Methscopolamine Petition

FDA denies a petition asking it to require compliance with a guidance and taken enforcement action against non-compliant manufacturers of methscopolam...

Human Drugs

Merck sBLA on Keytruda Dosing Option Rejected

FDA issues Merck a complete response letter on a supplemental BLA seeking to update the dosing frequency for Keytruda (pembrolizumab) to include a 400...

Medical Devices

ResMed Recalls Stellar 100 & 150 Ventilators

ResMed recalls its Stellar 100 and 150 Non-invasive and Invasive Ventilators due to a sound alarm failure.

Human Drugs

FDA Issues EIR for Aurobindo Pashamylaram Unit 4

FDA issues an Establishment Inspection Report to Aurobindo Pharma for its Pashamylaram Unit 4 injectable manufacturing facility.

Human Drugs

More than 1,000 ANDAs Approved in 2019

Office of Generic Drugs director Sally Choe says more than 1,000 ANDAs were given final or tentative approval in 2019.

Medical Devices

Abbott Vascular Dilation Catheter Recall is Class 1

FDA says an Abbott Vascular recall of specific lots of coronary dilation catheters due to a balloon issue is Class 1.