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Common Combo Product Designation Mistakes To Be Outlined In Upcoming Guidance

 
• By Derrick Gingery

US FDA's Office of Combination Products hopes Q&A guidance will help lower high refusal rate on requests for designation.

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More guidance is expected from the US FDA in the coming months to help combination product sponsors avoid mistakes in their requests for designation and reverse a low filing rate.

Nearly 87% of the designation requests received in fiscal year 2017 were not filed or withdrawn because of missing information or other problems. Office of Combination Products Director Thinh Nguyen...

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