FDA Webview
X
about-us-banner

FDA Related News

Home / Articles / FDA Related News
Animal Drugs

Clinical Researchers Plead Guilty to Fraud

Two clinical research facility owners plead guilty in Florida federal court to conspiracy to commit wire fraud in connection with their work on two cl...

latest-news-card-1
Human Drugs

FDA Warns 6 Firms on Unapproved Fat-Dissolving Drugs

FDA warns six companies that they are marketing unapproved fat-dissolving drugs.

latest-news-card-1
Human Drugs

Sydnexis NDA Accepted for Pediatric Myopia

FDA accepts a Sydnexis NDA for SYD-101 (topical low-dose atropine) for treating progression of pediatric myopia.dr

Medical Devices

Beckman Coulter 510(k) Cleared for Clinical Analyzer

FDA clears a Beckman Coulter Diagnostics 510(k) for its DxC 500i Clinical Analyzer.

latest-news-card-1
Human Drugs

Top Device Science Official Leaves FDA

CDRH chief scientist and deputy Center director Doug Kelly abruptly resigns after less than five years at the agency.

latest-news-card-1
Human Drugs

Glenmark Pharma Hit With 483 After India Inspection

FDA belatedly inspects Indias Glenmark Pharmaceuticals after a recent ProPublica investigative report found that the agency hadnt shifted any attentio...

latest-news-card-1
FDA General

FDA Taps Jim Traficant as Chief of Staff

FDA names former business consultant Jim Traficant as chief of staff where he will oversee and lead the agencys major initiatives.

latest-news-card-1
Human Drugs

Mineralys Nets Positive Data in Hypertension Drug Studies

Mineralys Therapeutics reports positive topline data from its pivotal Launch-HTN Phase 3 and pivotal Advance-HTN Phase 2 trials assessing lorundrostat...

latest-news-card-1
Human Drugs

FDA Clarifies Compounding Policy for GLP-1 Products

FDA clarifies its policies for compounders of GLP-1 products for weight-loss and treating diabetes following a court ruling in Texas that denied a pre...

latest-news-card-1
Medical Devices

Dexcom Hit With Warning After 2 Inspection

Dexcom says it received an FDA Warning Letter following inspections at the companys facilities in San Diego, CA and Mesa, AZ.