FDA issues guidance for Impact of Certain Provisions of the Revised Common Rule on FDA-Regulated Clinical Investigations

FDA announced the availability of a new guidance entitled “Impact of Certain Provisions of the Revised Common Rule on FDA-Regulated Clinical Investigations.” This guidance clarifies that certain provisions of the 2018 Requirements related to informed consent are not inconsistent with FDA’s current policies and guidances.  The guidance also reminds stakeholders that FDA’s current regulations for expedited review and continuing review must be followed for FDA-regulated studies.

The revisions to the Department of Health and Human Services’ (HHS’) Federal Policy for Protection of Human Research Subjects (45 CFR 46, Subpart A; “the Common Rule” or “2018 Requirements”) have created certain differences between FDA’s human subject regulations and HHS’ human subject regulations.  While FDA intends to undertake rulemaking to harmonize, to the extent practicable and consistent with other statutory provisions, its regulations with the 2018 Requirements consistent with Section 3023 of the 21st Century Cures Act, we recognize the potential for confusion in the interim for sponsors, investigators, and IRBs who are involved in both HHS-regulated research and FDA-regulated clinical investigations. This guidance is intended to clarify the impact of certain provisions of the 2018 Requirements on FDA-regulated clinical investigations.

The guidance is available to download on FDA’s website

FDA Issues Final Rule on Clinical Investigator Disqualification

The U.S. Food and Drug Administration (FDA) announced an amendment that will expand the scope of clinical investigator disqualification.  Under this new regulation, if the FDA Commissioner determines that a clinical investigator is ineligible to receive one kind of test article (drugs, devices or new animal drugs), the investigator will also be ineligible to conduct any clinical investigation that supports an application for a research or marketing permit for other kinds of products regulated by FDA.  This final rule is intended to help ensure adequate protection of research subjects and the quality and integrity of data submitted to FDA.  This rule will become effective May 30, 2012.

The final rule is available using the following web link: 

FDA Guidance: FDA Acceptance of Foreign Clinical Studies Not Conducted Under an IND

FDA issued the following guidance, "FDA Acceptance of Foreign Clinical Studies Not Conducted Under an IND, Frequently Asked Questions."  The guidance is intended to clarify the requirements if 21 CFR 312.120 and it also provides recommendations for IND's or MAA"s on how to provide evidence of GCP compliance of a non-IND foreign clinical study. 


FDA Guidance: IND Applications for PET Drugs

FDA's draft guidance summarizes the investigational new drug application (IND) process for unapproved positron emission tomography (PET) drugs, makes recommendations on how to submit an IND, provides advice on investigational PET drug access options, and describes the process for requesting permission to charge for an investigational PET drug.  Read the guidance at www.fda.gov:  Investigational New Drug Applications for Positron Emission Tomography (PET) Drugs (PDF - 461KB)