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Latest From Legislation
US FDA commissioner says he would be happy to work with Congress on a legislative solution on the issue, but emphasized his priority is for the agency to develop a system itself to discourage REMS abuse.
US FDA would need additional appropriations to cover all activities contemplated in the legislation – and the bill appears to need a pay-for because it increases the deficit.
It’s not realistic to expect sudden changes in US agency’s regulation of medical product communications to healthcare providers and payers given the other pressing issues facing new Commissioner Scott Gottlieb, Medical Information Working Group’s Klasmeier says.
Hearings in July and the fall will follow, but if the first session was any indication, industry doesn't have anything to worry about.
Association for Accessible Medicines report highlights continuing upward trend of cost savings from generic drugs; trade group argues legislative proposals addressing restricted distribution misuse are key to accelerating savings.
CBER Director Peter Marks says center will mobilize necessary resources to make sure these provisions are implemented; Marks also offered comments in opposition to 'right-to-try' legislation.
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