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Combination Product Human Factors Final Guidance In Clearance, OCP Says

Priorities from the Office of Combination Products

 
• By Hannah Daniel

The OCP presented its priorities for 2023 and beyond at the RAPS/AFDO Combination Products Summit on 8 November.

Attendees at an OCP session at the RAPS/AFDO Combination Products Summit in Columbus, OH. • Source: Hannah Daniel

The US Food and Drug Administration’s Office of Combination Products has set its sights on publishing the final guidance for human factor designs for combination products, an agency official said Tuesday at the RAPS/AFDO Combination Products Summit in Columbus, OH.

The draft guidance was published in February 2015, and combination product experts have been anxiously awaiting an update since. (Also...

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