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FDA's Policy On Releasing More Drug Application Material Coming Soon

This article was originally published in The Tan Sheet

Executive Summary

The drug industry should have a better idea by the end of February how far FDA might go in releasing information currently withheld from the public, including complete response letters, withdrawn applications and other similar material

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Disclosure Of NDA Filings Recommended In Transparency Report

Firms may have to marshal legal arguments to prevent public disclosure of drug development milestones, including OTC switch filings, following the FDA Transparency Task Force's recommendation that the agency disclose when applications are submitted and withdrawn

Disclosure Of NDA Filings Recommended In Transparency Report

Firms may have to marshal legal arguments to prevent public disclosure of drug development milestones, including OTC switch filings, following the FDA Transparency Task Force's recommendation that the agency disclose when applications are submitted and withdrawn

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