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Cross labeling oncology drugs in combination regimens: guidance for industry
Cross labeling oncology drugs in combination regimens: guidance for industry
- Collection:
- Health Policy and Services Research
- Contributor(s):
- Center for Drug Evaluation and Research (U.S.), issuing body.
Center for Biologics Evaluation and Research (U.S.), issuing body.
Oncology Center of Excellence (U.S.), issuing body. - Publication:
- Silver Spring, MD : Center for Drug Evaluation and Research, November 2022
- Language(s):
- English
- Format:
- Text
- Subject(s):
- Antineoplastic Combined Chemotherapy Protocols
Drug Labeling -- legislation & jurisprudence
Government Regulation
United States
United States. Food and Drug Administration - Genre(s):
- Guideline
Technical Report - Abstract:
- Drug approvals in oncology often build on treatment effects by adding drugs to current regimens or by combining investigational drug products in a combination regimen, creating new regimens with greater efficacy. 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. Cross labeling is defined as inclusion of information in approved product labeling of two or more oncology drug products approved in a combination regimen for a specific indication. The purpose of this guidance is to describe the Food and Drug Administration’s (FDA’s) current recommendations about including relevant information in labelng for oncology drugs approved for use in a combination regimen, including important considerations for cross labeling of these drugs. This guidance does not address all issues that might arise relating to labeling for oncology drugs for use in a combination regimen. Applicants proposing cross labeling for oncology drug combination regimens should contact the review division for information on cross labeling of their individual products. This guidance also does not address circumstances in which a drug product and a biological product packaged separately constitute a cross-labeled combination product as defined in 21 CFR 3.2(e). In general, FDA’s guidance documents do not establish legally enforceable responsibilities. Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidances means that something is suggested or recommended, but not required.
- Copyright:
- The National Library of Medicine believes this item to be in the public domain. (More information)
- Extent:
- 1 online resource (1 PDF file (6 pages))
- NLM Unique ID:
- 9918590088006676 (See catalog record)
- Permanent Link:
- http://resource.nlm.nih.gov/9918590088006676