SUPPLEMENTARY INFORMATION:

I. Background

FDA is announcing the availability of a guidance for industry entitled “Influenza: Development of Drugs for Treatment and/or Prophylaxis.” Because of the public health implications of both epidemic and pandemic influenza, the variable nature of the disease, the limited therapeutic options, and challenges in studying new options, FDA is issuing guidance to assist sponsors in all phases of influenza drug development.

This guidance addresses nonclinical development, early phases of clinical development, phase 3 protocol designs and endpoints for the treatment of both uncomplicated and serious influenza, and protocol designs for prevention of symptomatic influenza. Other issues that are addressed in this guidance include the role of animal data in an influenza drug development program, and considerations relating to the potential for emergency access to influenza drugs, including advance development of protocols for further exploration and verification of drug effects under epidemic and pandemic conditions.

A draft notice of availability of this guidance was published for comment in the Federal Register of February 20, 2009 (74 FR 7908). Comments we received on the draft guidance have been considered and the guidance has been revised as follows: (1) Clarification on the size of a safety database needed to support filing of a new drug application for the treatment of serious influenza; (2) elaboration on why virologic endpoints are not currently acceptable primary efficacy endpoints in phase 3 studies; (3) a recommendation for the inclusion of sensitive and specific assays ( e.g., real-time polymerase chain reaction assay) for laboratory confirmation of influenza infection to assist in defining the infected population for analyses in influenza treatment trials; and (4) additional statements regarding proposals for potential emergency use authorizations of antiviral drugs for influenza.

This guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The guidance represents the Agency's current thinking on developing drugs for treatment and/or prophylaxis of influenza illness. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statutes and regulations.

II. The Paperwork Reduction Act of 1995

This guidance refers to previously approved collections of information that are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of information in 21 CFR parts 312 and 314 have been approved under OMB control numbers 0910-0014 and 0910-0001, respectively.

III. Comments

Interested persons may submit to the Division of Dockets Management ( seeADDRESSES ) either electronic or written comments regarding this document. It is only necessary to send one set of comments. It is no longer necessary to send two copies of mailed comments. Identify comments with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. ( printed page 20690)

IV. Electronic Access

Persons with access to the Internet may obtain the document at either http://www.fda.gov/​Drugs/​GuidanceComplianceRegulatoryInformation/​Guidances/​default.htm or http://www.regulations.gov.