新分子实体和新化学实体不一样.pdfVIP

NDA 505(b)(1) of the FDC Act • Application used for approval of a new drug (for clinical use) whose active ingredient has not previously been approved • Requires extensive data to establish: – Safety and effectiveness of the drug for the proposed uses – Production methods are adequate to ensure identity, strength, quality, purity of the drug – Proposed labeling is appropriate and contains all necessary information 1 NDA 505(b)(2) of the FDC Act • Application for approval of a new drug that relies, at least in part, on data not developed by the applicant • Must provide information to establish: – Safety and effectiveness of the drug for its proposed uses • Not necessarily full reports of studies—may rely on published literature, findings of safety and effectiveness for already approved products, studies conducted by others with no right of reference, and/or FDA’s PET Safety and Effectiveness Notice – Production methods are adequate to ensure identity, strength, quality, purity of the drug – Proposed labeling for the drug is appropriate and contains all necessary information 2 ANDA 505(j) of the FDC Act • Application used for approval of a “generic” version of a drug that has already been approved • Relies on FDA’s finding that the previously approved reference listed drug (RLD) is safe and effective • Must provide information to establish that the proposed generic is the same as the RLD in: – Active ingredient – Strength – Dosage form – Route of administration – Conditi