FDA Annual Status Report Information and Other Submissions for Postmarketing Requirements and Commitments Using Forms FDA 3988 and FDA 3989

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Annual Status Report Information and Other Submissions for Postmarketing Requirements and Commitments Using Forms FDA 3988 and FDA 3989[附网盘链接]是Food And Drug Administration发布的FDA标准，适用于US。

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Draft — Not for Implementation 1 Annual Status Report Information and Other Submissions for 2 Postmarketing Requirements and Commitments: Using Forms 3 FDA 3988 and FDA 3989 1

4 Guidance for Industry 5 6 7 8 This draft guidance, when finalized, will represent the current thinking of the Food and Drug 9 Administration (FDA or Agency) on this topic. It does not establish any rights for any person and is not 10 binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the 11 applicable statutes and regulations. To discuss an alternative approach, contact the FDA staff responsible 12 for this guidance as listed on the title page. 13 14 15 16 I. INTRODUCTION 17 18 This guidance is intended for applicants that are required to report annually on the status of 19 postmarketing studies and clinical trials for human drug and biological products under section 20 506B of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 356b) and its 21 implementing regulations at 21 CFR 314.81(b)(2)(vii) and 601.70. In other words, this guidance 22 is intended for applicants that are required by statute or regulation, or that have agreed in writing, 23 to conduct postmarketing studies or clinical trials concerning a product’s clinical safety, clinical 24 efficacy, clinical pharmacology, and nonclinical toxicology as postmarketing requirements 2

25 (PMRs) or postmarketing commitments (PMCs). This guidance describes the purpose and 1

This guidance was prepared by the Office of New Drugs in the Center for Drug Evaluation and Research (CDER) in cooperation with the Office of Strategic Programs in CDER and the Center for Biologics Evaluation and Research (CBER) at the Food and Drug Administration. 2

See section 506B of the FD&C Act; 21 CFR 314.81(b)(2)(vii) and 601.70. The FDA defines postmarketing studies or clinical trials for which annual status reports (ASRs) must be submitted under section 506B of the FD&C Act as those concerning a human drug or biological product’s clinical safety, clinical efficacy, clinical pharmacology, or nonclinical toxicology that are either required by FDA (PMRs) or that are committed to, in writing, (PMCs) either at the time of approval of an application or a supplement or after approval of an application or supplement. See 21 CFR 314.81(b)(2)(vii) and 601.70. The FDA interprets section 506B of the FD&C Act to apply to postmarketing studies and clinical trials that are required under the Pediatric Research Equity Act (section 505B of the FD&C Act (21 U.S.C. 355c); 21 CFR 314.55(b) and 601.27(b)), the animal efficacy rule (21 CFR 314.610(b)(1) and 601.91(b)(1)), accelerated approval (section 506(c)(2)(A) of the FD&C Act (21 U.S.C. 356(c)(2)(A); 21 CFR 314.510 and 601.41), and the Food and Drug Administration Amendments Act of 2007 (FDAAA) (section 505(o)(3) of the FD&C Act (21 U.S.C. 355(o)(3)). FDAAA makes a distinction between studies and clinical trials. See section 505(o)(3) of the FD&C Act. We interpret the term study in section 506B of the FD&C Act and its implementing regulations at 21 CFR 314.81(b)(2)(vii) and 601.70 to include clinical trial. To account for the distinction between studies and clinical trials in FDAAA, we refer to both studies and clinical trials in this guidance.

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