Generic Industry Not Sold On Benefits Of FDA Emerging Technology Program

FDA’s calls for more generic industry participation in its Emerging Technology Program fell on deaf ears at recent meeting, with several complaining about the costs and value of investing in new manufacturing technologies.

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Generic Industry Presses FDA For More Incentives To Participate In Emerging Technology Program • Source: Shutterstock

Pharmaceutical industry officials attending the Association for Accessible Medicines' 4-6 November GRx-Biosims meeting in North Bethesda, MD, said that there are a number of factors that preclude their participation in the US Food and Drug Administration's Emerging Technology Program despite the benefits the head of the program said emerging technologies can deliver, such as more robust manufacturing processes and reduced risk of drug shortages.

Challenges include the high cost of developing these technologies, the lack of outside support, and uncertainty as to whether these...

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