Zdrowie i gospodarka · 12/10/2017

FDA Announces Draft Guidance for Reconsideration Requests Under GDUFA

The FDA has released a draft guidance outlining procedures for resolving scientific and regulatory issues related to reconsideration requests for abbreviated new drug applications, aimed at improving the review process for applicants seeking to challenge FDA decisions.

Source: Federal Register — Food and Drug AdministrationOpen original release →

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