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Executive Summary

NUMBER OF ANDA APPLICATIONS REQUIRED FOR CERTAIN VARIATIONS of solid oral and injectable dosage forms will be reduced to a single ANDA or AADA (abbreviated antibiotic drug application) under a May 25 interim "Policy and Procedure Guide" issued by FDA's Division of Generic Drugs. The guide points out that "applicants have been required to submit separate ANDAs or AADAs for each drug dosage form and also for each variation of that dosage form." This requirement has "multiplied the paperwork submitted by industry and has multiplied the number of documents that FDA must review, act upon, and archive," the guide notes. The new policy has been developed to "reduce the burden." The revised policy "only applies to tablets, capsules and injectable dosage forms. The policy is unchanged for other dosage forms," the guide emphasizes. Charts included with the interim guide explain which variations are eligible to be included in a single application. The division will begin accepting new original applications that consolidate variations into a single application as of Oct. 1. Between Oct. 1 and Dec. 31, "consolidation will be an option," but as of Jan. 1, 1991 "it will be required," the guide says.

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