FDA Clinical Guidelines

FDA Clinical Guidelines are a set of rules and standards that oversee the design, conduct, and reporting of clinical trials for new medical products. They ensure that studies are conducted ethically, safely, and reliably, protecting participant rights and generating accurate data. These guidelines help confirm that any new drugs or treatments are effective and safe before they can be approved for public use. They address aspects like informed consent, study protocols, data management, and safety monitoring, providing a framework for researchers to follow and maintain scientific integrity throughout the development process.