Tag: risk-based monitoring

risk-based monitoring

Regulatory/FDA

New FDA Guidance on Clinical Trial Design—and an Admonition from Commissioner Gottlieb

New FDA Guidance on Clinical Trial Design—and an Admonition from Commissioner Gottlieb

March 18, 2019 — With mere days left before his departure as FDA Commissioner, Dr. Scott Gottlieb is trying to focus attention on one of the lesser-known of his major initiatives – improving the design of clinical trials in drug development. In a statement released along with the publication of a new guidance, Gottlieb highlighted […]

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