Regulatory Information

Clinical Trials Guidance Documents

Guidance documents accessible from this page represent the Agency's current thinking on good clinical practice (GCP) and the conduct of clinical trials. As with all guidance documents, they do not create or confer any rights for or on any person and do not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statute and regulations. However, in many places throughout these documents, specific regulations are cited and the requirements of the regulations are reiterated. The regulations are enforceable.

Guidance documents included under the umbrella title of FDA Information Sheets represent the agency's current thinking on protection of human subjects in research. The date following the title of each document represents the most recent update for that subject. Many documents were last updated prior to the enactment of good guidance practice requirements. As further updates become necessary, reformatting of some documents may therefore be necessary. While most will still be included under the umbrella of Information Sheets, some may be accessible separately after update.


Draft Guidance Documents
Draft guidance documents have been proposed and are issued for public comment. Each FDA draft document lists how to submit comments to the agency.


Some Web links (URLs) embedded within guidance documents may have changed since the document was published. If you find a link that does not work, please try searching for the document using the document title. For more assistance, go to Contact FDA.

 

Drugs and Biologics Guidance Documents

Page Last Updated: 12/19/2014
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.