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FDA & OHRP Guidance

FDA overview

The FDA provides oversight for clinical trials of investigational drugs, biologic products, and medical devices.

Useful links on the FDA website

FDA regulations

Clinical trials involving investigational drugs, biologics, and/or devices are governed by specific FDA regulations. Numerous parties involved in the clinical trials process, including study sponsors, principal investigators, and Institutional Review Boards, are subject to applicable FDA regulations.

FDA guidance documents and information sheets

The FDA provides guidance documents that describe the FDA's current thinking about issues related to FDA-regulated clinical trials. In addition, the FDA publishes Information Sheets that provide guidance and recommendations for IRBs, clinical investigators, and sponsors to help them fulfill their responsibilities to protect human subjects who participate in FDA-regulated research.

Highlighted guidances

Guidance on FDA form completion

Guidance on clinical trial registration on clinicaltrials.gov

Device-related guidance

FDA forms/templates

The FDA requires that study sponsors and clinical investigators complete forms specific to the type of study that is being conducted.

Adverse event reporting 

Office for human research protection (OHRP) guidance

The OHRP governs clinical trials that are federally-funded.

The OHRP website provides multiple guidance documents, which represent its current thinking on a topic. These documents should be viewed as recommendations.

The OHRP website also has a "Frequently Asked Questions" section that serves as a good reference for IRBs, sponsors, and investigators.

FDA and OHRP compliance findings

OHRP: significant findings and concerns noted in compliance oversight determination letters over the last several years are outlined in the following document.

FDA: The most recent FDA Warning Letters can be accessed on the FDA website

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