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Regulatory Update, March 2016

Tuesday, March 1, 2016

Final FDA Guidance on Developing Antiretroviral Drugs for HIV-1 Treatment

In the November 3, 2015 Federal Regis­ter, the FDA announced the availability of a final guidance document titled “Hu­man Immunodeficiency Virus-1 Infec­tion: Developing Antiretroviral Drugs for Treatment.” The purpose of this guidance is to assist sponsors in all phases of drug development of antiretroviral drugs and therapeutic biologic products for the treat­ment of human immunodeficiency virus-1 (HIV-1) infection. This includes nonclini­cal development, early phases of clinical development, phase III protocol designs, and endpoints for the treatment of HIV.

This guidance specifically addresses HIV drug development in populations in need of additional HIV drugs for main­taining HIV suppression including trial designs for heavily treatment-experienced patients; use of early virologic assessments as primary endpoints in trials evaluating antiretroviral drugs in heavily treatment-experienced patients; recommended trial durations based on medical need; and risk-benefit in the targeted patient population.

This guidance replaces the guidance for industry titled “Antiretroviral Drugs Using Plasma HIV RNA Measurements—Clinical Considerations for Accelerated and Tradi­tional Approval” issued October 2002.

Public comments resulted in revisions to: (1) clarify definitions of treatment-naïve and treatment-experienced patient catego­ries with respect to both drug susceptibil­ity and clinical history; (2) add recommen­dations for trial designs that investigate switching treatment regimens in patients who are suppressed on current therapy; and (3) briefly discuss recommendations for labeling claims for safety endpoints.

Submit written comments to the Divi­sion of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fish­ers Lane, Room 1061, Rockville, MD 20852. Identify comments with Docket No. FDA- 2013-D-0589.

OHRP/FDA Draft Guidance on IRB Meeting Minutes

In the November 5, 2015 Federal Regis­ter, the Office for Human Research Pro­tections (OHRP) and the FDA announced the availability of a draft guidance titled “Minutes of Institutional Review Board (IRB) Meetings: Guidance for Institu­tions and IRBs.” The purpose of the draft guidance is to assist institutions and IRBs in preparing and maintaining minutes of IRB meetings (also referred to in the guid­ance as minutes) that meet the regulatory requirements for minutes set forth in FDA and HHS regulations. The draft guidance also provides general recommendations on the type and amount of information to be included in the minutes.

Because IRBs have been cited in OHRP determination letters and FDA warning let­ters as having inadequate minutes, OHRP and FDA are providing recommendations on the type and amount of information to in­clude in minutes in order to help IRBs meet their respective regulatory requirements. To enhance human subject protection and reduce regulatory burden, OHRP and FDA have been actively working to harmonize the agencies’ regulatory requirements and guid­ance for human subject research.

Best Practices for Sponsor/FDA Communication during Drug Development

In the December 9, 2015 Federal Register, the FDA announced the availability of a draft guidance document titled “Best Practices for Communication between IND Sponsors and FDA during Drug Development.” The pur­pose of this guidance is to describe best prac­tices and procedures for timely, transparent, and effective communications between IND sponsors and FDA at critical junctures in drug development, which may facilitate ear­lier availability of safe and effective drugs to the American public.

As part of the Prescription Drug User Fee Amendments of 2012, FDA’s Center for Drug Evaluation and Research (CDER) and Cen­ter for Biologics Evaluation and Research (CBER) agreed to publish a joint guidance for industry and review staff on best prac­tices for communication between IND spon­sors and FDA during drug development.

CDER and CBER incorporated input from interested parties who responded to a notice published in the Federal Register on October 29, 2014, or who provided input directly to CDER’s Enhanced Communi­cation Team.

This guidance describes FDA’s philoso­phy regarding timely interactive communi­cation with IND sponsors as a core activ­ity; the scope of appropriate interactions between the review team and the sponsor; the types of advice appropriate for sponsors to seek from FDA in pursuing their drug development program; the general expec­tations for the timing of FDA response to IND sponsor inquiries; best practices and communication methods to facilitate inter­actions between the FDA review team and the IND sponsor during drug development; and expectations on appropriate methods and frequency of such communications. This guidance does not apply to communi­cations or inquiries from industry trade or­ganizations, consumer or patient advocacy organizations, other government agencies, or stakeholders not pursuing an IND devel­opment program.

The Regulatory Update is excerpted from Research Practitioner, Volume 17, Number 1, January-February 2016.

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