FDA Fights Problems With Pre-ANDA Meeting Requests

More Pre-ANDA Meeting Requests Are Being Denied

More meeting requests are being denied because the sponsor's pre-meeting package was incomplete, the agency said.

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THE FDA GRANTED MORE PRE-ANDA MEETINGS FOR COMPLEX GENERICS THROUGH THE FIRST NINE MONTHS OF FY 2019 THAN IN ALL OF FY 2018 • Source: Shutterstock

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