FDA Best Practices in Developing Proprietary Names for Human Nonprescription Drug Products; Draft

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Best Practices in Developing Proprietary Names for Human Nonprescription Drug Products; Draft[附网盘链接]是FDA于过去发布的FDA标准，适用于美国。

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Draft — Not for Implementation 1

1 Guidance for Industry 2 3 Best Practices in Developing Proprietary Names for Human 4 Nonprescription Drug Products 5 6 7 8 This draft guidance, when finalized, will represent the current thinking of the Food and Drug 9 Administration (FDA or Agency) on this topic.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 establish 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 I. INTRODUCTION 15 FDA is issuing this guidance to help sponsors of human nonprescription drug products develop 2

16 proprietary names for those products. This guidance describes best practices to help minimize 17 proprietary name-related medication errors and otherwise avoid adoption of proprietary names 18 that contribute to violations of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and its 19 implementing regulations. It also describes the framework FDA uses in evaluating proposed 20 proprietary names that is available to sponsors to use for nonprescription drug products before a 21 product bearing that proprietary name is marketed. This guidance does not address the 22 designation of established names or proper names. 23 24 This guidance applies to all human nonprescription drug products, including those approved 3

25 under a new drug application (NDA), abbreviated new drug application (ANDA) , or biologics 4

26 license application (BLA) , and those that can be marketed without approved applications in 27 accordance with requirements for nonprescription drugs under section 505G of the FD&C Act 5

28 (21 U.S.C. 355h) ( often referred to as over-the-counter (OTC) monograph drugs). In this 1

This guidance was prepared by the Office of Surveillance and Epidemiology, Division of Medication Error Prevention and Analysis in the Center for Drug Evaluation and Research (CDER), and the Advertising and Promotional Labeling Branch in the Center for Biologics Evaluation and Research (CBER) at the Food and Drug Administration. 2

Terms that appear in bold type upon first use are described in the Glossary, as they are used in this guidance. 3

With regard to NDAs and ANDAs, see section 505(b) and (j) of the FD&C Act (21 U.S.C. 355(b) and (j)). 4

See section 351 of the Public Health Service Act (42 U.S.C. 262). 5

Under section 505G, to be legally marketed without a new drug application approved under section 505, a nonprescription drug product must meet requirements that include conformity with applicable conditions for nonprescription use for the drug or class of drugs (such as those described in section 505G(a)(1)-(3) or established by order under section 505G(b)), as well as conformity with the general requirements for nonprescription drugs, which include labeling requirements under the Act and regulations. 1

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