Knowledge base

Abbreviated New Drug Application Fraud (ANDA)

An application submitted for the approval of a drug which contains no clinical trials sponsored by or on behalf of the applicant; instead, it relies on the approved application of another drug with the same active ingredient to establish safety and efficacy. Drugs approved via this method are referred to as generic drugs. Generic drug fraud can take the same form as fraud involving drugs approved by an NDA (New Drug Application), including but not limited to: falsified representations made in the ANDA submission; falsified records to cover up deviations from approved manufacturing processes; and false annual reports.

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