FDA Cross Labeling Oncology Drugs in Combination Regimens Guidance for Industry Draft

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Draft — Not for Implementation 1 Cross Labeling Oncology Drugs in Combination Regimens 1

2 Guidance for Industry 3 4 5 6 7 This draft guidance, when finalized, will represent the current thinking of the Food and Drug 8 Administration (FDA or Agency) on this topic. It does not establish any rights for any person and is not 9 binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the 10 applicable statutes and regulations. To discuss an alternative approach, contact the FDA staff responsible 11 for this guidance as listed on the title page. 12 13 14 15 16 I. INTRODUCTION 17 2

18 Drug approvals in oncology often build on treatment effects by adding drugs to current 3

19 regimens or by combining investigational drug products in a combination regimen, creating new 20 regimens with greater efficacy. Traditionally, applicants have not requested changes to the 21 labeling of a previously approved drug to describe how to use that drug in a new regimen (cross 4 5

22 labeling). However, there has recently been an increasing number of applications that have 1

This guidance has been prepared by the Oncology Center of Excellence in cooperation with the Center for Drug Evaluation and Research and the Center for Biologics Evaluation and Research at the Food and Drug Administration. 2

For the purposes of this guidance, all references to drug or drugs include both human drugs approved under section 505 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and therapeutic biological products licensed under section 351 of the Public Health Service Act. 3

For the purpose of this guidance, a combination regimen refers to two or more drugs that are marketed separately, where at least one of the drugs has an approved indication for the combination based upon one or more adequate and well-controlled clinical trials. For the purposes of this guidance, codevelopment of two or more new investigational drugs for use in combination has the meaning described in the guidance for industry Codevelopment of Two or More New Investigational Drugs for Use in Combination (June 2013). We update guidances periodically. To make sure you have the most recent version of a guidance, check the FDA guidance web page at https://www.fda.gov/regulatory-information/search-fda-guidance-documents. 4

Although this guidance uses the term cross labeling with respect to combination regimens that may include a drug and a biological product, this guidance is not intended to address the circumstances under which a drug and biological product labeled for such combined use constitute a cross-labeled combination product as described at 21 CFR 3.2(e)(3) and (4). Combination products governed by 21 CFR part 3 may have additional regulatory requirements not addressed in this guidance. 5

The term application in this guidance refers to a new drug application under section 505 of the FD&C Act (21 U.S.C. 355) or a biologics license application under section 351 of the Public Health Service Act (42 U.S.C. 262) or an efficacy supplement to such application.

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