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Nda Policy In The Late 1970's

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FDA accepts the abbreviated new drug application (ANDA) for pre-1962 generic drugs but did not accept ANDA for generic equivalent marketed after 1962. Thus, the FDA implemented the “paper” NDA policy in the late 1970’s. The “paper” NDA policy, allows a generic drug manufacturer to get approval to market the drug without performing duplicative clinical studies. The generic drug manufacturer would get its drug approved by submitting the evidence on its safety and efficacy on the basis of the published scientific data or articles. The innovator drug manufacturer did not please the “paper” NDA policy and challenged the policy in Burroughs Wellcome Co v. Schweiker. To support the manufacturer claim of safety and efficacy of the drug there were

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