Archive for March 2023

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 supply chain vulnerabilities. Source: Drug Industry Daily

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.” Source: Drug Industry Daily

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 (AMD). Source: Drug Industry Daily

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 role in guiding the agency. Source: Drug Industry Daily

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 Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research (CBER), in the New England Journal of Medicine (NEJM) Thursday. Source: Drug Industry…

As part of its efforts to harmonize with international standards for exchange of medicinal product data, the FDA has issued a final guidance on the use of five International Organization for Standardization (ISO) Identification of Medicinal Products (IDMP) standards. Source: Drug Industry Daily

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 Hetlioz (tasimelteon) for jet lag. Source: Drug Industry Daily

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 prices in PBMs’ Part D bids, said experts who testified at a House Finance Committee hearing Thursday. Source: Drug Industry Daily

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 Parkinson’s Disease 2023 meeting. Source: Drug Industry Daily