Abstract
AbstractA summary of the Abbreviated New Drug Application (ANDA) submission and review process is presented. The numerous significant factors that have impacted the process are highlighted (e.g., the passage of the Drug Price Competition and Patent Term Restoration Act of 1984, and the publication of the NDA rewrite), and the effects of these changes on ANDA submissions and the Division of Generic Drug’s policies and procedures are discussed. The criteria used in evaluating an ANDA submission in terms of acceptablity and completeness are set forth. Also, problems currently encountered in ANDA submissions are identified. Industry, FDA, and the public benefit when firms submit acceptable, complete ANDAs which can be processed expediently and culminate in approval.
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