Module 5 Presentations

18/07/2024

Clinical Trials Database

 www.clinicaltrials.gov  Operated by the National Institutes of Health  Virtually all drug/biologics and device clinical trials (except Phase I) must be listed  Form 3674 accompany submissions to the FDA to show that Sponsor companies have complied with the requirements of FDAAA (Food and Drug Administrative Amendments Act 2007)  Information must be registered within 21 days of enrolling the first patient

The Organisation for Professionals in Regulatory Affairs

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Fees: USA

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*Fees do apply for certain product types

The Organisation for Professionals in Regulatory Affairs

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