Would FDA support these approaches: Flipped Clinical Trials and One Indication, One Standardized Protocol, Multiple IMPs?

On 7 November 2019 the FDA held a public meeting on Promoting Effective Drug Development Programs: Opportunities and Priorities for FDA's Office of New Drugs

The purpose of this public meeting is to solicit from external stakeholders specific, actionable policy suggestions that could be implemented in the near-term by the review staff of the Office of New Drugs (OND) in the Center for Drug Evaluation and Research (CDER) to promote effective drug development programs without compromising our regulatory standards for assessment of safety and effectiveness. Dr. Peter Schiemann, Managing Partner at Widler & Schiemann LTD, presented the cases of Flipped Clinical Trials and One Indication, One Standardized Protocol, Multiple IMPs Sharing Data from Standard Therapies.

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