FDA outlines requirements for accepting international clinical evidence
What happened
The Food and Drug Administration (FDA) stated that it will accept clinical evidence from outside the United States if the investigations adhered to Good Clinical Practice (CGP) regulations and the information is applicable for regulatory purposes. To qualify, sponsors must demonstrate that the evidence was obtained in accordance with GCP, which includes review by an ethics committee and documentation of freely given informed consent. These regulations are outlined in 21 CFR 812 and 21 CFR 50.
From raps.org
Why it matters
These guidelines establish strict standards for how international clinical trials must be conducted to be considered valid by the FDA. This requirement impacts the regulatory pathway for medical devices and pharmaceuticals seeking approval in the United States.
From raps.org
Who's involved
- FDARegulatory agency responsible for evaluating clinical evidence
- Center for Devices and Radiological HealthDivision of the FDA that handles clinical evidence evaluation
- United States of AmericaJurisdiction from which the FDA derives its authority
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The entities involved
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