03-19802. Guideline for the Clinical Evaluation of Analgesic Drugs; Withdrawal of Guidance

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice; withdrawal.

SUMMARY:

The Food and Drug Administration (FDA) is announcing the withdrawal of a guidance entitled “Guideline for the Clinical Evaluation of Analgesic Drugs,” which was issued on December 1, 1992. The guidance is outdated and no longer reflects FDA's current thinking on development of analgesic drugs. FDA is revising the guidance and will issue a draft for public comment in the future.

DATES:

Comments on agency guidances are welcome at any time.

FOR FURTHER INFORMATION CONTACT:

Barbara J. Gould, Center for Drug Evaluation and Research (HFD-550), Food and Drug Administration, 5600 Rockville Pike, Rockville, MD 20850, 301-827-2504.

Dated: July 28, 2003.

Jeffrey Shuren,

Assistant Commissioner for Policy.