In this two-part series, FDAnews examines the dramatic impact of artificial intelligence (AI) on medical devices and the significant challenges it presents for regulators. Part 1 is an overview of…
A trio of Republicans on the House Energy and Commerce Committee have called on the FDA to explain what steps the agency is taking to address persistent drug shortages and…
The U.S. Solicitor General is asking the Supreme Court to consider a case — Teva Pharmaceuticals v. GlaxoSmithKline (GSK) — that highlights the pharmaceutical industry’s ongoing dispute over “skinny labeling.”…
The FDA has granted Pixium Vision Breakthrough Device status for its Prima System, an investigational device for restoring partial vision for people with blindness caused by dry age-related macular degeneration…
Source: Drug Industry Daily
After an FDA career that has spanned more than three decades, former FDA Acting Commissioner Janet Woodcock — who now serves as principal deputy commissioner — still plays a significant…
Despite the approaching end of the COVID-19 public health emergency (PHE) in the U.S., medical products approved under emergency use authorizations (EUA) will remain available for the foreseeable future, said…
GOTHENBURG, SWEDEN — The approval of two Alzheimer’s disease-modifying therapies is giving the field a much-needed shot in the arm, experts said during a panel discussion at the Alzheimer’s and…
The government needs to step in and regulate the rebates that pharmacy benefit managers (PBMs) extract from drug companies and Medicare needs to do a better job of policing the…
A federal court has ruled the FDA must share with Vanda Pharmaceutical its internal deliberation notes on why it denied Vanda’s supplemental new drug application (sNDA) for its sleep-disorder drug…