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FDA Policy Says Right-to-Try Talks Are Between Providers, Sponsors

 
• By Derrick Gingery

New internal policy says the US agency cannot force a drug maker to supply an unapproved drug to a patient for expanded access and that the provider must seek company approval to provide the product.

FDA entrance sign 2016

FDA makes clear in its new internal policy on expanded access that while it will speed approval of applications, it cannot mandate a company to provide an investigational drug for a patient and will not even facilitate those discussions.

It serves as another reminder that FDA's role in the expanded access process is limited even as efforts to expand...

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The FDA law establishing REMS authority does not preempt a West Virginia law that would restrict mifepristone use in the state, an appeals court said, a decision that could have broader ramifications for the agency’s authority to ensure drug access.

US FDA’s Drugs Center Lost Hundreds Of Staff Through June With 600 RIFs Coming

 
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The official separation of those impacted by the reduction-in-force and some others who are leaving the agency are not yet reflected in CDER employee gains and losses data.

More from Agency Leadership

Access Risks Loom For All Drugmakers With Fourth Circuit Mifepristone Decision

 
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The FDA law establishing REMS authority does not preempt a West Virginia law that would restrict mifepristone use in the state, an appeals court said, a decision that could have broader ramifications for the agency’s authority to ensure drug access.

US FDA’s Drugs Center Lost Hundreds Of Staff Through June With 600 RIFs Coming

 
• By Derrick Gingery, Sue Sutter, and Sarah Karlin-Smith

The official separation of those impacted by the reduction-in-force and some others who are leaving the agency are not yet reflected in CDER employee gains and losses data.

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