FDA Publishes Responses to Good Clinical Practice Inquiries

August 22, 2022

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.


January 5, 2016

Best Practices for FDA Communication with IND Sponsors

On December 9, 2015, the FDA released a draft guidance entitled, “Best Practices for Communication Between IND Sponsors and FDA During Drug Development.” The guidance attempts to promote timely,...

June 30, 2016

New Draft Guidance Addresses Process & Principles of Giving Gifts to FDA Commissioner

On Wednesday, June 29th the FDA issued a draft guidance, entitled “Gifts to the Food and Drug Administration: Evaluation and Acceptance: Draft Guidance for the Public and Food and Drug Administration...

January 5, 2016

Best Practices for Meeting-Related Communication with FDA

In December 2015, the FDA released a draft guidance, which provides IND sponsors with a number of recommendations and best practices for communicating with the FDA. Among those included in the draft...