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Regulatory Update, October 2016

Saturday, October 1, 2016

FDA Publishes Several Draft Guidance Documents

The FDA recently published several draft guidance documents related to the treatment of particular diseases. Interested parties may submit electronic or written comments on these draft guidance documents as instructed above by the dates indicated below and with the indicated Docket Numbers included in the comments.

Bacterial Vaginosis: Developing Drugs for Treatment

In the July 14, 2016 Federal Register, the FDA announced the availability of a draft guidance titled “Bacterial Vaginosis: Developing Drugs for Treatment.” The purpose of this guidance is to assist sponsors in the clinical development of drugs for the treatment of bacterial vaginosis (BV). This draft guidance helps define enrollment criteria for BV trials and recommends that such trials be superiority trials. The draft guidance reflects recent developments in scientific information that pertain to drugs being developed for the treatment of BV, including the characterization of the primary efficacy endpoint. Submit comments by October 12, 2016 identified with Docket No. FDA-2016-D-1659.

Ulcerative Colitis: Clinical Trial Endpoints

In the August 8, 2016 Federal Register, the FDA announced the availability of a draft guidance titled “Ulcerative Colitis: Clinical Trial Endpoints.” The purpose of this guidance is to assist sponsors in the clinical development of drugs for the treatment of ulcerative colitis (UC) in adult and pediatric patients, specifically regarding efficacy endpoints for UC clinical trials.

UC is a chronic, relapsing disease characterized by diffuse mucosal inflammation of the colon. UC involves the rectum and it may extend proximally in a contiguous pattern to affect part of the colon or the entire colon. Clinical manifestations of active disease include bloody diarrhea (with or without mucus), urgency, tenesmus, abdominal pain, weight loss, fever and malaise. In patients with extensive or severe inflammation, acute complications such as severe bleeding and toxic megacolon may occur. There is an increased risk of colorectal cancer in UC patients compared to the general population; risk factors include long duration of disease, extensive colonic involvement, severe inflammation and epithelial dysplasia, and childhood-onset disease. The signs and symptoms of UC in adults and children are similar; however, abdominal pain, disease involving the entire colon, extra-intestinal manifestations, proctitis (among girls) and disease severity necessitating colectomy are more common in children. Submit comments by October 7, 2016 identified with Docket No. FDA-2016-D-2319.

Codevelopment of an IVD Companion Diagnostic Device with a Therapeutic Product

In the July 15, 2016 Federal Register, the FDA announced the availability of a draft guidance titled “Principles for Codevelopment of an In Vitro Companion Diagnostic Device with a Therapeutic Product.” This draft guidance is intended to be a practical guide to assist therapeutic product sponsors and in vitro diagnostic device (IVD) sponsors in developing a therapeutic product with an accompanying IVD companion diagnostic, a process referred to as codevelopment. It describes general principles to guide codevelopment to support obtaining contemporaneous marketing authorization for the therapeutic product and its corresponding IVD companion diagnostic; certain regulatory requirements that sponsors should be aware of as they develop such products; considerations for planning and executing a therapeutic product clinical trial that also includes the investigation of an IVD companion diagnostic; and administrative issues in the submission process for the therapeutic product and the IVD companion diagnostic. Submit comments by October 13, 2016 identified with Docket No. FDA-2016-D-1703.

OHRP and FDA Publish Draft Guidance on IRB Written Procedures

In the August 2, 2016 Federal Register, the Office for Human Research Protections (OHRP) and the FDA announced the availability of a draft guidance titled “Institutional Review Board (IRB) Written Procedures: Guidance for Institutions and IRBs.” The purpose of this draft guidance is to assist IRB administrators, IRB chairpersons and other institutional officials responsible for preparing and maintaining written procedures for IRBs. The draft guidance is intended for IRBs and institutions responsible for review and oversight of human subject research under the Department of Health and Human Services (HHS) or FDA regulations, or both.

In order to provide guidance on the appropriate content of written procedures, the agencies created an IRB Written Procedures Checklist to assist IRBs in preparing and maintaining detailed written procedures suitable for their institutions. The IRB Written Procedures Checklist incorporates the HHS and FDA regulatory requirements for IRB written procedures and additional topics that are recommended to be included in written procedures. The draft guidance, when made final, will supersede OHRP’s July 1, 2011 “Guidance on Written IRB Procedures” and FDA’s 1998 “Appendix H: A Self-Evaluation Checklist for IRBs” (formerly part of FDA’s Information Sheet Guidance for IRBs, Clinical Investigators and Sponsors).
To ensure comments are considered before release of the final guidance version, submit electronic or written comments on the draft by October 3, 2016. Submit comments as instructed above and identify them with Docket No. FDA-2016-D-1605. 

The Regulatory Update is excerpted from Research Practitioner, Volume 17, Number 05, September-October 2016.

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