Discovery Groups: The Detectives of Cell Biology

Abstract

Both Industry and the FDA benefit when firms submit acceptable, complete Abbreviated New Drug Applications (ANDAs) which can be processed expediently and culminate in approval. An overview of the mechanics of the ANDA submission and review process is presented, and current problem areas in the submission process are identified. The criteria used in evaluating an ANDA submission in terms of acceptability and completeness are set forth. The ANDA Management Information System used in the tracking of submissions under review in the Division of Generic Drugs is described.