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.

TAGS:

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to do if you experience delays in obtaining IND-related feedback from the FDA: In December 2015, the FDA released a draft guidance, which provides IND sponsors with a number of recommendations...

October 22, 2018

Human Subject Protection Regulations: Differences Between HHS’ & FDA’s Clinical Trial Rules

On Friday, October 12th, FDA issued a guidance document entitled “Impact of Certain Provisions of the Revised Common Rule on FDA-Regulated Clinical Investigations.” The document aims to help...

May 14, 2015

FDA Sets A Deadline For Electronic Submission Of Drug Applications

In a final guidance published in the Federal Register on May 5, FDA laid out the rules and specifications for providing regulatory submissions in electronic format. Perhaps more important than the...