FDA Distributing Scientific and Medical Publications on Risk Information for Approved Prescription Drugs and Biological Products—Recommended Practices

标准简介

Distributing Scientific and Medical Publications on Risk Information for Approved Prescription Drugs and Biological Products—Recommended Practices[附网盘链接]是Food&Drug Administration于过去发布的FDA标准，适用于United States。

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标准部分原文

Draft — Not for Implementation 1

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on Risk 3 Information for Approved Prescription Drugs and Biological 4 Products—Recommended Practices 5 6 7 This draft guidance, when finalized, will represent the Food and Drug Administration’s (FDA’s) current 8 thinking on this topic.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staff, call 12 the appropriate number listed on the title page of this guidance. 13 14 15 I. INTRODUCTION 16 17 This draft guidance describes the Food and Drug Administration’s (FDA’s or Agency’s) current 18 thinking on recommended practices for drug manufacturers (firms) and their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

19 follow if they choose to distribute to health care professionals or health care entities scientific 4,5,6

20 or medical journal articles that discuss new risk information for approved prescription drugs 21 marketed in the United States. The recommendations in this draft guidance are intended to 22 address issues specific to the distribution of new information about risks associated with a drug 23 that further characterizes risks identified in the approved labeling. 24 25 The recommendations in this draft guidance are intended to apply to distribution of new risk 26 information (as that term is further explained in section II of this document) for drugs intended 27 for human and animal use. Throughout this draft guidance, the Agency provides references to 28 regulations and guidances specific to drugs intended for human use. Unless otherwise indicated, 29 the Agency generally takes a similar approach when addressing the issues raised in this draft 30 guidance as they pertain to animal drugs. 31 32 FDA’s guidance documents, including this draft guidance, do not establish legally enforceable 33 responsibilities. Instead, guidances describe the Agency’s current thinking on a topic and should 1

This draft guidance has been prepared by the Center for Drug Evaluation and Research (CDER) in cooperation with the Center for Biologics Evaluation and Research (CBER) and the Center for Veterinary Medicine (CVM) at the Food and Drug Administration. 2

For purposes of this draft guidance, health care professionals include those providing care to either human or animal patients. 3

As used in this draft guidance, health care entities include hospitals, professional medical organizations, drug formulary committees, pharmacy benefit managers, health insurance issuers, group health plans, and Federal or State governmental agencies involved in the provision of health care or health insurance. For purposes of the draft guidance, health care entities also include any such similar organizations involved in animal health care. 4

As used in this draft guidance, the term drug includes drugs approved for use in humans or animals and drugs regulated as biological products licensed under section 351 of the Public Health Service Act (42 U.S.C. 262(a)). 5

For animal drugs, this draft guidance also applies to over-the-counter and Veterinary Feed Directive drugs. 6

This guidance does not apply to products regulated as medical devices.

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