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Gottlieb Talks Activist Role For FDA In Curbing REMS Abuse

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.

Drug Safety FDA

Generic Program Is Biggest Extra Item In Senate User Fee Reauthorization Bill

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.

Generic Drugs Legislation

Off-Label Communications: Near-Term ‘Seismic Shift’ In FDA Oversight Unlikely

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.

Advertising, Marketing & Sales Regulation

Drug Pricing 'Deeper Dive' Planned By Senate Cmte. As Industry Avoids First Blood

Hearings in July and the fall will follow, but if the first session was any indication, industry doesn't have anything to worry about.

Policy Pricing Debate

Generic Savings: REMS Obstruction, Not ANDA Backlog, Is Main Hindrance, AAM Says

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.

Pricing Debate Generic Drugs

Regenerative Medicines Provisions Of Cures Act A Top Priority For CBER

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.

Regenerative Medicine Legislation
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