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Competitive Generic Therapies Get Help With Development, But Not Goal Date

 
• By Derrick Gingery

Draft guidance says US FDA will try to expedite assessment of competitive generic therapy designees, but will not give shorter review goals.

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Sponsors will not automatically receive a priority assessment upon gaining a competitive generic therapy designation.

A competitive generic therapy designation alone will not guarantee a shorter assessment goal by US FDA, just a promise to finish as soon as possible.

The agency is willing to expedite its assessment of applications receiving the designation designed to encourage more generic entry in...

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