Zdrowie i gospodarka · 11/07/2019

FDA Releases Final Guidance on Live Case Presentations in IDE Clinical Trials

The FDA has released a final guidance document to help IRBs, industry, and FDA staff evaluate the appropriateness of live case presentations in IDE clinical trials, providing guidance on factors to consider and information to be included in IDE applications.

Source: Federal Register — Food and Drug AdministrationOpen original release →

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