Agency Guidance Snapshots

Digital Health Technologies for Remote Data Acquisition in Clinical Investigations

Guidance for Industry, Investigators, and Other Stakeholders
December 2023
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Summary: A digital health technology (DHT) is a system that uses computing platforms, connectivity, software, and/or sensors, for health care and related uses. This document summarizes recent agency guidance that provides recommendations for sponsors, investigators, and other stakeholders on the use of DHTs for remote data acquisition from participants in clinical investigations that evaluate medical products.

Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices

Draft Guidance for Industry and Food and Drug Administration Staff (Draft Guidance)
December 2023
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Summary: FDA recently issued draft guidance to clarify how FDA evaluates real-world data to determine whether they are of sufficient quality for generating real-world evidence that can be used in FDA regulatory decision-making for medical devices, such as new or expanded indications for use or postmarket surveillance. The draft guidance also provides expanded recommendations to sponsors considering using real-world evidence to support a regulatory submission for medical devices.

The purpose of this Agency Guidance Snapshot is to summarize the guidance and highlight how the guidance might impact Yale University and affiliate stakeholders who conduct or oversee human subjects research.

Public Health Service Policies on Research Misconduct: Notice of Proposed Rulemaking (NPRM)

October 2023
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Summary: This document summarizes the recent Notice of Proposed Rulemaking (NPRM), released by the Department of Health and Human Services (HHS), Office of the Secretary, Office of the Assistant Secretary for Health (OASH), and the Office of Research Integrity (ORI). The NPRM proposes to revise the Public Health Service (PHS) Policies on Research Misconduct. The proposed revisions are based on the experience ORI and institutions have gained with the regulation since it was released in 2005. ORI anticipates release of the final rule in the summer of 2024, with implementation to begin a minimum of 4 months afterward. ORI will aim for an effective date of January 1, 2025, to simplify institutional reporting.

Institutional Review Board (IRB) Review of Individual Patient Expanded Access Submissions for Investigational Drugs and Biological Products

Guidance for IRBs and Clinical Investigators
September 2023
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Summary: This document summarizes recent agency guidance that provides recommendations to institutional review boards (IRBs) clinical investigators and licensed physicians regarding the key factors and procedures IRBs should consider when reviewing individual patient expanded access submissions, including for reviews conducted by a single member of the IRB, to fulfill its obligations under 21 CFR part 56.

Informed Consent Guidance for IRBs, Clinical Investigators, and Sponsors

August 2023
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Summary: On August 15, 2023, the U.S. Food and Drug Administration (FDA) issued a new guidance document on informed consent (the “Final Guidance”). This guidance finalizes the draft “Informed Consent Information Sheet” from 2014 (the “Draft Guidance”) and supersedes FDA’s guidance from 1998, “A Guide to Informed Consent.” FDA’s issuance of the Final Guidance follows the Agency’s continuing efforts in recent years to modernize and streamline the clinical trial enterprise. The document is structured to first present general guidance on FDA’s regulatory requirements for informed consent and a discussion of the roles of IRBs, clinical investigators, sponsors, and FDA related to informed consent, followed by a series of frequently asked questions.

The purpose of this Agency Guidance Snapshot is to summarize the guidance and highlight how the guidance might impact Yale University and affiliate stakeholders who conduct or oversee human subjects research.

Psychedelic Drugs: Considerations for Clinical Investigations

Guidance for Industry (Draft Guidance)
June 2023
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Summary: The U.S. Food and Drug Administration (FDA or Agency) recently issued draft guidance to provide general considerations to sponsors (including sponsor-investigators) developing psychedelic drugs for treatment of medical conditions (e.g., psychiatric disorders, substance use disorders).

The purpose of this Agency Guidance Snapshot is to summarize the guidance and highlight how the guidance might impact Yale University and affiliate stakeholders who conduct or oversee human subjects research.

Frequently Asked Questions: Limited Institutional Review Board Review and Related Exemptions

(Draft Guidance)
June 2023
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Summary: This document summarizes recent agency draft guidance regarding the concept of limited IRB review and provides information about how limited review may be conducted. This document also discusses IRB and investigator responsibilities when reviewing and conducting exempt research that requires limited IRB review as a condition of exemption. Note that limited IRB review is a provision that is only included in the 2018 Requirements. If a research study is covered by the pre-2018 Requirements, then limited IRB review is not a consideration.

Decentralized Clinical Trials for Drugs, Biological Products, and Devices

(Draft Guidance)
May 2023
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Summary: On May 1, 2023, the United States Food and Drug Administration (FDA) released draft guidance titled “Decentralized Clinical Trials for Drugs, Biological Products, and Devices - Guidance for Industry, Investigators, and Other Stakeholders.” This draft guidance provides recommendations for sponsors, investigators, and other stakeholders regarding the implementation of decentralized clinical trials (DCTs) for drugs, biological products, and devices. In this guidance, a DCT refers to a clinical trial where some or all of the trial-related activities occur at locations other than traditional clinical trial sites. The purpose of this Agency Guidance Snapshot is to summarize the guidance and highlight how the guidance might impact Yale University and affiliate stakeholders who conduct or oversee human subjects research.

Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations

Questions and Answers (Draft Guidance)
March 2023
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Summary: This document summarizes recent agency draft guidance to sponsors, clinical investigators, institutional review boards (IRBs), contract research organizations (CROs), and other interested parties on the use of electronic systems, electronic records, and electronic signatures in clinical investigations of medical products, foods, tobacco products, and new animal drugs. The draft guidance provides recommendations regarding the requirements, including the requirements under 21 CFR part 11, under which FDA considers electronic systems, electronic records, and electronic signatures to be trustworthy, reliable, and generally equivalent to paper records and handwritten signatures executed on paper.

Research Involving Children as Subjects and Not Otherwise Approvable by an Institutional Review Board

Process for Referrals to Food and Drug Administration and Office for Human Research Protections (Draft Guidance)
March 2023
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Summary: This document summarizes recent agency draft guidance intended to assist institutional review boards (IRBs), institutions, investigators, and sponsors in understanding the processes used for review of research involving children as subjects that is not otherwise approvable by an IRB and has been referred to the Food and Drug Administration (FDA) under 21 CFR 50.54, the Office for Human Research Protections (OHRP) under 45 CFR 46.407, or both, for review.