FDA Brief Summary and Adequate Directions for Use Disclosing Risk Information in Consumer-Directed Print Advertisements and Promotional Labeling for Prescription Drugs

标准简介

Brief Summary and Adequate Directions for Use Disclosing Risk Information in Consumer-Directed Print Advertisements and Promotional Labeling for Prescription Drugs[附网盘链接]是于过去发布的FDA标准，适用于US。

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标准部分原文

Draft — Not for Implementation 1 Brief Summary and Adequate Directions for Use: Disclosing Risk 2 Information in Consumer-Directed Print Advertisements and 3 Promotional Labeling for Prescription Drugs 4 1 5 Guidance for Industry 6 7 8 This revised draft guidance, when finalized, will represent the current thinking of the Food and Drug 9 Administration (FDA or Agency) on this topic.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 create 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FDA staff responsible 12 for this guidance as listed on the title page. 13 14 15 16 I. INTRODUCTION 17 18 This revised draft guidance provides recommendations on the disclosure of risk information in 19 prescription drug product advertisements and promotional labeling in print media directed 20 toward consumers with respect to the brief summary requirement and the requirement that 2

21 adequate directions for use be included with promotional labeling. The recommendations 22 describe an alternative disclosure approach that FDA refers to as a consumer brief summary. 23 This revised draft guidance does not focus on the presentation of risk information in the main 24 body of promotional labeling or advertisements and does not apply to promotional materials 25 directed toward health care professionals. 26 27 This revised draft guidance responds to stakeholder requests for specific guidance on the 28 disclosure of risk information to consumers and incorporates recent social science research 29 results (Aikin, O’Donoghue, et al. 2011). This revised draft guidance revises the draft guidance 30 entitled Brief Summary: Disclosing Risk Information in Consumer-Directed Print 31 Advertisements (issued January 2004). Additionally, this revised draft guidance (Revision 2) has 32 been reissued to incorporate animal prescription drugs; there are no other revisions to the revised 33 draft guidance for industry issued February 9, 2015 (80 FR 6998). 1 This guidance has been prepared by the Office of Prescription Drug Promotion (OPDP) in the Center for Drug Evaluation and Research (CDER) in consultation with the Center for Biologics Evaluation and Research (CBER) and the Center for Veterinary Medicine (CVM) at the Food and Drug Administration. 2

The recommendations of this revised draft guidance also apply to biological products that are approved for marketing under section 351 of the Public Health Service Act (PHS Act). Because each biological product also meets the definition of “drug” under the Federal Food, Drug, and Cosmetic Act (FD&C Act), it is also subject to regulation under provisions of the FD&C Act applicable to drugs, as well as the regulations implementing these provisions, except that a biological product licensed under section 351 of the 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 PHS Act section 351(j) (42 U.S.C. 262(j)). References to “drugs” in this guidance therefore also include biological products for use in humans that fall within the definition, as well as both human and animal prescription drugs. 1

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