FDA oversight of clinical trials is “grossly inadequate,” say experts

Author:

Demasi Maryanne

Publisher

BMJ

Subject

General Engineering

Reference18 articles.

1. FDA. Summary basis for regulatory action: Comirnaty. 2021. www.fda.gov/media/151733/download.

2. FDA. Summary basis for regulatory action: Spikevax. 2022. www.fda.gov/media/155931/download.

3. FDA Center for Drug Evaluation and Research. Summary review: other relevant regulatory issues. 2020. www.accessdata.fda.gov/drugsatfda_docs/nda/2020/214787Orig1s000SumR.pdf#page=29

4. FDA. Conducting remote regulatory assessments: draft guidance for industry. July 2022. www.fda.gov/media/160173/download.

5. FDA Department of Health and Human Services. The Food and Drug Administration’s oversight of clinical trials. 2007. www.oig.hhs.gov/oei/reports/oei-01-06-00160.pdf.

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