FDA supports transparency and collaboration in drug approval process as clinical data summary pilot concluded

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On Mar. 26, 2020, the FDA reported that it had become increasingly clear that the FDA needed to take a more collaborative approach to the drug approval process. The pilot aimed to test a new process for selecting, redacting and posting on the FDAメs public website summaries of information that the agency uses in making marketing approval decisions..

In 2018, the Center for Drug Evaluation and Research implemented the Clinical Data Summary Pilot Program, a voluntary pilot program designed to evaluate whether disclosing certain information included within clinical study reports following approval of a new drug application improves public access to drug approval information.

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Source: U.S. Food and Drug Administration
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