Food and Drug Administration - May 25, 2005
Richard Klein and Kimberly Struble

The Food and Drug Administration (FDA) is issuing draft guidance to assist product sponsors in the development of antiviral drug products and to serve as a starting point for understanding the nonclinical and clinical virology data important to support clinical trials of antiviral agents. This guidance focuses on nonclinical and clinical virology reports, which are essential components in the review of investigational antiviral drugs.

Topics in the guidance include studies defining the mechanism of action, establishing specific antiviral activity of the investigative drug, submitting data on the development of viral resistance to the investigational drug, and providing data identifying cross-resistance to approved drugs having the same target.

The recommendations in the guidance are based on the review experience with antiviral drugs of the FDA Division of Antiviral Drug Products (DAVDP) and input from pharmaceutical sponsors and the scientific community. Because of the experience, history, and lessons learned with HIV-1 studies, the guidance focuses on studies commonly used to evaluate HIV-1 drugs and uses them as a model for future studies of drugs to treat other viruses. Since the field of virology is dynamic and continually evolving, this guidance will be revised as new information accumulates and as circumstances warrant.

The Federal Register document, including instructions for submitting comments to the agency, is available at http://www.fda.gov/OHRMS/DOCKETS/98fr/05-10431.htm

The draft guidance is available at http://www.fda.gov/cder/guidance/6568dft.htm

Guidances on the overall organization of investigational new drug (IND) applications and new drug applications (NDAs) can be found at http://www.fda.gov/cder/regulatory/applications/default.htm. Sponsors are encouraged to contact the Agency early in the development of an investigational antiviral drug to facilitate the review and approval process. To assist prospective sponsors, the Agency accepts informal submissions in an abbreviated IND format (i.e., pre-INDs) for review and comment. Pre-INDs are especially useful in instances where applicants are unfamiliar with the process for evaluating investigational drug products in humans. Information about submitting pre-INDs can be found at http://www.fda.gov/cder/ode4/preind/getting.htm.

FDA guidances describe the Agency's current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited.

Richard Klein, Office of Special Health Issues

Kimberly Struble, Division of Antiviral Drug Products

Food and Drug Administration

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SOURCE: Food and Drug Administration (FDA).

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