FDA Announces Major Proposed Rule Amending Hatch-Waxman Regulations

On February 6, 2015, the Food and Drug Administration (FDA) published in the Federal Register (FR) a comprehensive proposed rule (80 FR 6802) to amend agency regulations governing Abbreviated New Drug Applications (ANDAs) and 505(b)(2) New Drug Applications (505(b)(2) NDAs) and the patent listing and certification provisions fundamental to the operation of the Drug Price Competition and Patent Restoration Act of 1984 (the Hatch-Waxman Act).

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