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Complex Generic Mid-Cycle Meetings: US FDA Suggests Taking The Date Offered

 
• By Derrick Gingery

US FDA offers best practices and tips to ensure successful meetings, although few have been conducted so far. 

Woman uses an inhaler during an asthma attack, close-up
The US FDA does not want complex generic sponsors to delay mid-cycle meetings if possible, because it could render them less productive.

The US Food and Drug Administration has little experience conducting mid-assessment cycle meetings for generic drug sponsors, but already cautions that trying to reschedule may not improve the outcome.

Mid-cycle meetings with agency officials are available for complex generic drug sponsors to discuss issues that have been found in...

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Generic Drug Office’s Policy Staff Returning To US FDA

 
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More from Biosimilars & Generics

US FTC Continues Effort To Eliminate Orange Book’s Improper Patent Listings

 
• By Urtė Fultinavičiūtė

In a somewhat surprising move, President Trump’s Federal Trade Commission is continuing a crusade to delist improper listings from the FDA’s Orange Book. Law firm Polsinelli’s chair Chad Landmon discussed the impact of the move on the generic drug industry.

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The group had been laid off as part of the 1 April reduction-in-force, which led to missed guidance publication deadlines.

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