Earlier this month I wrote about the importance of clinical trial transparency and the FDA’s oversight. Today, I’d like to catch up with you about another critical component of FDA’s oversight of clinical studies: our work to harmonize clinical research regulations and to facilitate the development of medical products to benefit public health.
Modernizing Clinical Research Oversight
Efficient, well-designed clinical research is a critical element of the FDA’s public health mission to help advance development of safe, effective medical products for patients. Well-designed studies and reliable data inform the FDA’s decision-making about a product’s benefits and risks. The agency has taken several steps to advance clinical research and ultimately promote the generation of evidence needed to demonstrate the safety and effectiveness of medical products.
Additionally, we are working to harmonize our human subject protection regulations, where appropriate, with U.S. Department of Health and Human Service (HHS) Common Rule, a set of federal rules that protect people who participate in research. This work serves to make clinical research more efficient while protecting people participating in the research.
Increasing Options in Clinical Research to Facilitate Medical Product Development | FDA
Increasing Options in Research for Medical Product Development
FDA issued a final rule to help advance medical product development without compromising the rights, safety and welfare of people participating in research.
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