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Generic Drug Market Has Gaps, FDA Tells Firms In Solicitation For ANDAs

Executive Summary

US agency unveils plans to speed reviews of generic applications in areas with limited competition and offers a list of potential targets, but threat to brands may be limited.

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Generic Industry Gets 267 Reasons From FDA To Pursue ANDA Development

US agency’s list of off-patent, off-exclusivity drugs that lack generic versions is aimed at improving transparency and encouraging competition, but almost half the 267 listed products involve complex issues that would require further decision-making by FDA ahead of ANDA submission.

FDA Drug Pricing Policy Offers Short-Term PR Gain, More Long-Term Actual Benefit

Prioritizing ANDAs entering markets with fewer than three approved generics not expected to become a major advantage until first-cycle clearances increase.

FDA's Generic Policy Initiative Includes Choose-Your-Own-Agenda Meeting

US agency is seeking feedback from interested stakeholders about administrative steps it can take to better promote generic competition; July 18 meeting will involve only presentations from the public.

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