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.

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January 6, 2016

Obtaining IND-Related Feedback from FDA

What to do if you experience delays in obtaining IND-related feedback from the FDA: In December 2015, the FDA released a draft guidance, which provides IND sponsors with a number of recommendations...

January 2, 2014

FDA Guidance Follows USP Salt Policy & Aims to Make Conversions Between Salt Forms Simpler

The Food and Drug Administration (FDA) recently published a draft guidance that outlines the “Naming of Drug Products Containing Salt Drug Substances” in accordance with the recently implemented USP...

January 21, 2014

FDA Issues a Reminder on Excipients in Dietary Supplements

In the new guidance on substances that can be added to foods, including beverages and dietary supplements, the FDA reminds manufacturers that the excipients added to oral dosage forms of these...