FDA Distributing Scientific and Medical Publications on Unapproved New Uses — Recommended Practices - Revised Guidance

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Distributing Scientific and Medical Publications on Unapproved New Uses — Recommended Practices - Revised Guidance[附网盘链接]是Food&Drug Administration发布的FDA标准，适用于United States。

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Draft — Not for Implementation 1 Distributing Scientific and Medical Publications on Unapproved 1

2 New Uses — Recommended Practices 3 4 5 6 This draft guidance, when finalized, will represent the Food and Drug Administration’s (FDA’s) 7 current thinking on this topic. It does not create or confer any rights for or on any person and 8 does not operate to bind FDA or the public. You can use an alternative approach if the approach 9 satisfies the requirements of the applicable statutes and regulations. If you want to discuss an 10 alternative approach, contact the FDA staff responsible for implementing this guidance. If you 11 cannot identify the appropriate FDA staff, call the appropriate number listed on the title page of 12 this guidance. 13 14 15 16 I. INTRODUCTION 17 18 This guidance describes the Food and Drug Administration’s (FDA’s or Agency’s) current 19 thinking on recommended practices for drug and medical device manufacturers and their 2 3

20 representatives to follow when distributing to health care professionals or health care entities 21 scientific or medical journal articles, scientific or medical reference texts, or clinical practice 4 22 guidelines (CPGs) that discuss unapproved new uses for approved drugs or approved or cleared 5

23 medical devices marketed in the United States. For the purposes of this guidance, these 24 materials are generally referred to as scientific and medical publications. 25 1

This guidance was developed by the Center for Drug Evaluation and Research (CDER) in collaboration with the Center for Biologics Evaluation and Research (CBER) and the Center for Devices and Radiological Health (CDRH) in the Food and Drug Administration. 2

As used in this guidance, manufacturer means a person who manufactures a drug or device or who is licensed by such person to distribute or market the drug or device, or a representative of such a person. The term might also include the sponsor of the approved, licensed, cleared, or 510(k) exempt drug or device. 3

As used in this guidance, health care entity includes hospitals, professional medical organizations, drug formulary committees, pharmacy benefits managers, health insurance issuers, group health plans, and Federal or State governmental agencies involved in the provision of health care or health insurance. 4

The terms unapproved new use, unapproved use, and off-label use are used interchangeably in this guidance to refer to a use of an approved or cleared medical product that is not included in the product's approved labeling or cleared indications for use statement. Although this guidance focuses on unapproved uses of approved and cleared medical products, the recommendations in this guidance also apply to manufacturer distribution of publications that discuss unapproved new uses that are not included in the exemption from premarket notification for those class I or class II devices that are otherwise exempt from the requirement to submit a 510(k). 5

As used in this guidance, the terms drug and device refer to drugs and devices intended for use in humans, and include biological products licensed under section 351(a) of the Public Health Service (PHS) Act (42 U.S.C. 262(a)). See 42 U.S.C. 262(j). Different provisions govern the use of drugs in animals, which are not generally addressed in this guidance. See sections 512(a)(4) and (a)(5) of the Food, Drug & Cosmetic Act and this Agency’s regulations at 21 CFR part 530 for specific provisions related to the off-label (or extra-label) use of approved animal and human drugs in animals. 1

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