FDA Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities – Questions and Answers
标准简介
Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities – Questions and Answers [附网盘链接]是FDA于不久之前发布的FDA标准，适用于United States。标准截图
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标准文档类型为Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities – Questions and Answers [附网盘链接]高清PDF版本（文字版），标准文档内可进行搜索，可以复制原文，可粘贴。标准部分原文
Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities — Questions and Answers 1
Guidance for Industry and Review Staff This guidance represents the current thinking of the Food and Drug Administration (FDA or Agency) on this topic. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. To discuss an alternative approach, contact the FDA office responsible for this guidance as listed on the title page. I. INTRODUCTION 2
This guidance provides answers to common questions regarding firms’ communication of health 3 4 5
care economic information (HCEI) regarding their prescription drugs and medical devices to 6
payors, formulary committees, or other similar entities with knowledge and expertise in the area of health care economic analysis (collectively referred to as payors). This guidance also addresses common questions relating to dissemination to payors of information about medical 7
products that are not yet approved or cleared for any use and dissemination to payors of information about unapproved uses of approved/cleared medical products. 1
This guidance has been prepared by the Office of Prescription Drug Promotion in the Center for Drug Evaluation and Research in cooperation with the Center for Biologics Evaluation and Research, the Center for Devices and Radiological Health, and the Office of the Commissioner at the Food and Drug Administration. 2
The term “firms” refers to medical product manufacturers, packers, and distributors, including representatives of these entities. 3
See Q.A.1/A.A.1 for a definition of HCEI. 4
Each biological product that also meets the definition of “drug” under the Federal Food, Drug, and Cosmetic Act (FD&C Act) is subject to provisions of the FD&C Act applicable to drugs, except that a biological product licensed under section 351 of the Public Health Service Act (PHS Act) is not required to have an approved new drug application under section 505 of the FD&C Act (21 U.S.C. 355). See section 351(j) of the PHS Act (42 U.S.C. 262(j)). For the purposes of this guidance, the term “drugs” means human prescription drugs, including those that are licensed as biological products. 5
The term “device” refers to a medical device intended for human use, including a device that is licensed as a biological product. 6
The terms “payors, formulary committees, or other similar entities” are discussed in Q.A.2/A.A.2 of this guidance. 7
The term “medical products” refers to both drugs and devices.
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