Submit written comments on this draft guidance by March 26, 2001.
General comments are welcome at any time.
Send one self-addressed adhesive label to assist the office in processing your request. 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. This draft guidance revises the July 1993 interim guidance. Among other things, in the review of abbreviated new drug applications, the Center for Drug Evaluation and Research generally has not considered different mechanisms of release, particularly for suppository, delayed, and controlled release products, as different dosage forms.