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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. Read More
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. Read More
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. Read More
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. Read More
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. Read More
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. Read More
If the FDA is forced to go back to fiscal 2022 levels — as House Republicans are proposing — there will be fewer inspections, new drug products won’t get approved and drug companies will flock to other countries, said FDA Commissioner Robert Califf during a fiscal 2024 budget hearing on Wednesday. Read More
Esperion is suing Daiichi Sankyo over a failure to pay a $300 million milestone payment for the cardiovascular drug Nexletol (bempedoic acid), a treatment for heterozygous familial hypercholesterolemia or established atherosclerotic cardiovascular disease. Read More
The FDA has approved the first over-the-counter (OTC) naloxone nasal spray — Emergent BioSolutions’ opioid overdose therapy Narcan, 4 mg — and is encouraging other producers to apply for OTC status. Read More