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US FDA Adcomm Modernization Includes How Meetings Are Scheduled

 
• By Derrick Gingery

Agency officials are considering developing policies for when an advisory committee meeting is appropriate, in part because of the workload associated with them. Could fewer meetings result?

Scheduling notebook
Advisory committee scheduling is difficult, which is prompting the FDA to update policies on when the meetings are appropriate. • Source: Alamy

The US Food and Drug Administration’s advisory committee scheduling policy could be updated as part of an ongoing modernization initiative, potentially impacting the number of meetings that could be held.

Kevin Bugin, acting deputy director of operations in the FDA Office of New Drugs, said that because advisory committee meetings...

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Slowdown: US FDA’s 2025 Novel Approvals Are On Below-Average Pace

 
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US FDA’s CRL Release More Incremental Than ‘Radical’ Transparency

 
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The transparency initiative collects CRLs already made public in approval packages on its drugs@fda site to post on the openFDA public portal.

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US FDA’s CRL Release More Incremental Than ‘Radical’ Transparency

 
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The transparency initiative collects CRLs already made public in approval packages on its drugs@fda site to post on the openFDA public portal.

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This is an update of recommendations from the European Medicines Agency's Committee for Medicinal Products for Human Use on the authorization of new medicines in the EU, and updates on EU marketing authorization changes recommended by the CHMP.