FDA Publishes Responses to Good Clinical Practice Inquiries: FDA oversees clinical trials to ensure they are designed, conducted, analyzed and reported according to federal law and FDA’s regulations. The agency’s oversight of clinical trials protects the rights, safety, and welfare of people participating in clinical trials, and supports the development of safe and effective medical products. The agency addresses inquiries related to good clinical practice and human subject protection policies on an ongoing basis. The downloadable spreadsheet below includes inquiries that have been submitted to the FDA as well as the agency’s replies to each inquiry and is searchable by different fields such as topic, date, etc.
Good clinical practice inquiries and responses 2017 - 2021
See the FDA archive for inquiries for inquiries prior to 2017. Contact gcpquestions@fda.hhs.gov with questions.