How Drug Effects Are Assessed In Renally Impaired Patients Could Be Headed For A Change
US FDA advisory committee finds merit in each of four industry-suggested alternative approaches to the current paradigm for assessing the impact of renal impairment on drug exposures; agency's own 2010 draft guidance does not reflect its current thinking on the design of dedicated pharmacokinetic studies.
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FDA should amend its new renal testing guidance to reflect real-world conditions and ease the burden - in at least one area - for sponsors, according to an FDA advisory committee. With an eye toward facilitating clinical testing, the panel recommended that the agency change its patient selection criteria for one segment of pharmacokinetics studies on the effect of renal impairment on drug dosing
FDA's recommendation that COVID-19 vaccine sponsors conduct two months of median follow-up to support an emergency use authorization may not be long enough, some experts say in what can be viewed as validation for agency's position in battle with White House.
There are 18 people on the committee that will issue the first recommendations on COVID-19 vaccine development and licensure. Among the experts are a University of Michigan epidemiologist who will serve as acting chairman and seven temporary voting members, two of whom required conflict-of-interest waivers.