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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
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
The White House has laid out “bold goals” to use biomanufacturing breakthroughs to produce at least 25 percent of all active pharmaceutical ingredients (API) for small-molecule drugs in the U.S. within five years. Read More
The Senate Commerce, Science and Transportation Committee has passed a bill that would force pharmacy benefit managers (PBM) to be upfront about their often murky pricing practices and compel them to stop what legislators are calling unfair and deceptive conduct that drives up costs for consumers. Read More
GOTHENBURG, SWEDEN — The FDA correctly approved Biogen’s Aduhelm (aducanumab) in 2021 because the drug met the criteria for disease modification the agency had laid down for Alzheimer’s disease (AD) drug sponsors years before, according to a former FDA employee. Read More