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FDA Research Participation Program General Instructions 1. All documents must be in English or include an official English translation. 2. Complete the application form, and attach the following:
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The FDA Research participation program involves individuals or organizations conducting research that involves FDA-regulated products.
Researchers and organizations conducting research that involves FDA-regulated products are required to file the FDA Research participation program.
To fill out the FDA Research participation program, researchers and organizations need to provide information about their research activities, FDA regulations applicable to their research, and submit the required forms and documentation.
The purpose of the FDA Research participation program is to ensure that research involving FDA-regulated products is conducted in compliance with applicable regulations and to facilitate communication and collaboration between the FDA and researchers.
The FDA Research participation program requires the reporting of information such as the nature of the research, the FDA-regulated products involved, the methodologies used, potential risks and benefits, and any previous FDA interactions or approvals.
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