FDA Related News

Human Drugs

Inspection Findings Sideline UCB Psoriasis Drug

FDA sends UCB a complete response letter on its BLA for psoriasis-treating bimekizumab, citing deficiencies from a recent preapproval inspection as th...

Human Drugs

Scathing FDA-483 Hits Sun Pharma Over GMPs

A just-released, scathing (XXX INSERT XXX)23-page Form FDA-483 cites 10 GMP deficiencies at Sun Pharmaceutical Industries Halol manufacturing facility...

Human Drugs

Lilly Once-weekly Diabetes Injection Approved

FDA approves an Eli Lilly NDA for Mounjaro (tirzepatide), a once-weekly injection to improve blood sugar control in adults with Type 2 diabetes, as an...

Medical Devices

New BD COR Molecular Diagnostic Platform Cleared

FDA clears a BD (Becton, Dickinson) 510(k) for its new automated, high-throughput infectious disease molecular diagnostics platform, BD COR.

Medical Devices

Medtronic Onyx Frontier Drug-eluting Stent OKd

FDA approves a Medtronic PMA for the Onyx Frontier drug-eluting stent, indicated for treating patients with coronary artery disease.

FDA Role in Medical Isotope Development

CDER medical office Joseph Rajendran explains FDAs role in developing technology to produce medical isotopes without using highly enriched uranium.

FDA General

FDA Enterprise Modernization Action Plan

FDA provides an overview of its new Enterprise Modernization Action Plan effort.

Medical Devices

FDA Needs Unauthorized Test Enforcement Policy: GAO

The Government Accountability Office says FDA should develop a policy on starting and ending enforcement discretion for unauthorized tests in future p...

Human Drugs

6 Observations in Aurobindo Inspection

Aurobindo reports receiving a six-item FDA 483 after an inspection at its Unit VII oral drug manufacturing unit in Jadcherla, Hyderabad, India.

Medical Devices

QSR Proposed Revisions Will Advance Harmonization: Post

Pharmatech Associates managing director Stephanie Gaulding discusses the effects of an FDA proposed revision to the medical device Quality System Regu...