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  • Lorrie D. Divers, President, QRCP Solutions, Inc.

Recently Published Guidance from the FDA

There have been a number of draft and final guidance documents published by the US Food and Drug Administration (FDA) in the past several weeks.

Here are several relevant to clinical research.

Draft Guidance Documents:

Expansion of the Abbreviated 510(k) Program: Demonstrating Substantial

Equivalence through Performance Criteria Guidance for Industry

In this draft guidance, the FDA is proposing to expand “the potential use of the Abbreviated 510(k) Program, allowing for less burdensome demonstrations of substantial equivalence for certain device types while maintaining the statutory standard for demonstrating substantial equivalence. The guidance describes an optional pathway for certain, well-understood device types, where a submitter would demonstrate that a new device meets FDA-identified performance criteria to demonstrate the device is as safe and effective as a legally marketed device (predicate device).” The FDA is accepting comments on this draft guidance until July 11, 2018.

Investigational In Vitro Diagnostics in Oncology Trials: Streamlined Submission Process for Study Risk Determination Guidance for Industry

The purpose of this draft guidance is “to describe an optional streamlined submission process for determining whether use of an investigational in vitro diagnostic (IVD) in a clinical trial for an oncology therapeutic is considered significant risk (SR), nonsignificant risk (NSR), or exempt. If found to be SR, such a trial may require approval of an investigational device exemption (IDE) in addition to an investigational new drug application (IND). FDA encourages sponsors to use the streamlined process described in this guidance when possible to reduce administrative burden on sponsors and FDA and to maintain the current level of regulatory review.” The FDA is accepting comments on this draft guidance until June 12, 2018.

Atopic Dermatitis: Timing of Pediatric Studies During Development of Systemic Drugs Guidance for Industry

This draft guidance “addresses FDA’s current thinking about the relevant age groups to study and how early in a drug’s development pediatric patients should be incorporated during development of systemic drugs for atopic dermatitis (AD). The recommendations in this guidance are based on input received from the March 9, 2015, Dermatologic and Ophthalmic Drug Advisory Committee (DODAC) meeting on this topic and review of medical literature and relevant statutes and regulations. This guidance does not address the technical aspects of drug development for pediatric patients with AD, which will be addressed in a future guidance.” Comments on this draft guidance are being accepted by the FDA until June 9, 2018.

To learn how to comment on FDA draft guidance documents, go to:

Final Guidance Documents:

E11(R1) Addendum: Clinical Investigation of Medicinal Products in the Pediatric Population Guidance for Industry

The Scope and Objective of this ICH Addendum states: “Pediatric drug development has evolved since the original guidance E11 Clinical Investigation of Medicinal Products in the Pediatric Population (ICH E11 (2000) published, requiring consideration of regulatory and scientific advances relevant to pediatric populations. This addendum does not alter the scope of the original guidance. ICH E11(2000), including this addendum (R1); is not intended to be comprehensive; other ICH guidances, as well as documents from regulatory authorities worldwide, the World Health Organization (WHO), and pediatric societies, provide additional detail. The purpose of the addendum is to complement and provide clarification and current regulatory perspective on topics in pediatric drug development.”

Special Protocol Assessment Guidance for Industry

This guidance “provides information on the procedures and general policies adopted by the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) for special protocol assessment (SPA). SPA is a process in which sponsors may ask to meet with FDA to reach agreement on the design and size of certain clinical trials, clinical studies, or animal studies (i.e., a Request for SPA (hereafter Request); see section III., Eligible Protocols and General Information) to determine if they adequately address scientific and regulatory requirements for a study that could support marketing approval.”

If you would like help interpreting these guidance documents, or wonder if there are others on topics of interest to you, please contact us at

Image Credit: Publish by Nick Youngson CC BY-SA 3.0 Alpha Stock Images

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