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As his confirmation to the top spot at the FDA hangs precariously in the balance, Robert Califf seems to be making a lot of concessions to lawmakers even as support for his nomination from the medical community and the industry swells. Read More
The FDA has finalized its guidance to help drug sponsors develop population pharmacokinetic (PK) analyses used in drug development to fine-tune dosing regimens. Read More
In a 269-page submission to U.S. Trade Representative, Katherine Tai, the Pharmaceutical Research and Manufacturers of America (PhRMA) spelled out the group’s objections to efforts by the World Health Organization (WHO) and other organizations to expand COVID-19 vaccines and treatments at the expense of intellectual property rights. Read More
To try to avoid supply chain disruptions based on licensing uncertainties, the FDA has issued a proposed rule on the standards for licensing wholesale drug distributors and third-party logistics providers. Read More
ViiV Healthcare’s Apretude (cabotegravir), a recently approved long-acting injectable for preventing HIV in adults and adolescents, isn’t cost-effective despite offering new hope against the deadly disease, a new analysis contends. Read More
Center for Drug Evaluation and Research (CDER) Director Patrizia Cavazzoni fielded questions from lawmakers yesterday on confirmatory trials for drugs that receive FDA’s accelerated approval, during a hearing on reauthorizing user fee programs for prescription drugs, generics and biosimilars. Read More