FDA Developing and Submitting Proposed Draft Guidance Relating to Patient Experience Data

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Developing and Submitting Proposed Draft Guidance Relating to Patient Experience Data[附网盘链接]是Food And Drug Administration发布的FDA标准，适用于U.S。

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Draft — Not for Implementation 1 Developing and Submitting Proposed Draft Guidance Relating to 2 Patient Experience Data 1

3 Guidance for Industry and Other Stakeholders 4 5 6 This draft guidance, when finalized, will represent the current thinking of the Food and Drug 7 Administration (FDA or Agency) on this topic. It does not establish any rights for any person and is not 8 binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the 9 applicable statutes and regulations. To discuss an alternative approach, contact the FDA staff responsible 10 for this guidance as listed on the title page. 11 12 13 14 I. INTRODUCTION 15 16 This guidance provides information on how a person can submit a proposed draft guidance 17 relating to patient experience data for consideration by FDA. This guidance is intended to assist 18 stakeholders seeking to develop and submit such proposed draft guidance to the Agency. In 19 addition, FDA recognizes that stakeholders may have other information on patient experience 20 data that they would like to share with FDA outside of the guidance process and thus provides 21 information on other ways stakeholders can advance drug development by sharing patient st

22 experience data. Section 3002(c)(5) of the 21 Century Cures Act (Cures Act) directs FDA to 23 issue guidance on how a person seeking to develop and submit a proposed draft guidance 24 relating to patient experience data for consideration by FDA may submit such proposed draft 2

25 guidance to the Agency. 26 27 In general, FDA’s guidance documents do not establish legally enforceable responsibilities. 28 Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only 29 as recommendations, unless specific regulatory or statutory requirements are cited. The use of 30 the word should in Agency guidances means that something is suggested or recommended, but 31 not required. 32 33 34 II. BACKGROUND 35 36 Under Section 569C(c) of the Federal Food, Drug, and Cosmetic Act (as amended by the Cures 37 Act), patient experience data “includes data that (1) are collected by any persons (including 38 patients, family members, and caregivers of patients, patient advocacy organizations, disease 39 research foundations, researchers, and drug manufacturers); and (2) are intended to provide 40 information about patients’ experiences with a disease or condition, including (A) the impact 41 (including physical and psychosocial impacts) of such disease or condition, or a related therapy 1

This guidance has been prepared by the Office of the Center Director and the Office of Regulatory Policy in the Center for Drug Evaluation and Research (CDER), in cooperation with the Center for Biologics Evaluation and Research (CBER), at the Food and Drug Administration. 2

See 21st Century Cures Act: https://www.congress.gov/114/plaws/publ255/PLAW-114publ255.pdf.

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