At FDA public meeting on drug prices . . .

Experts: FDA Should Hike Transparency Around Generic Delay Tactics

By Beth Wang / July 21, 2017 at 3:23 PM
FDA faces pressure from stakeholders to increase transparency around the citizen petition process, product hopping and other tactics used by brand makers to delay generic drugs from entering the market. Requiring a “competition statement” that says competition will not be decreased as a result of an Orange Book patent was one of several ideas suggested during an all-day public meeting Tuesday (July 18) on ways to speed generics to market. An FDA official floated “increasing transparency” around reformulation requests and...


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