Acute myeloid leukemia: developing drugs and biological products for treatment : guidance for industry

Acute myeloid leukemia: developing drugs and biological products for treatment : guidance for industry

Collection:
Health Policy and Services Research
Alternate Title(s):
Developing drugs and biological products for treatment
Uniform Title(s):
Acute myeloid leukemia (Center for Drug Evaluation and Research (U.S.))
Contributor(s):
United States. Food and Drug Administration, issuing body.
United States. Food and Drug Administration. Office of Medical Products and Tobacco. Oncology Center of Excellence, issuing body.
Center for Drug Evaluation and Research (U.S.), issuing body.
Center for Biologics Evaluation and Research (U.S.), issuing body.
Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, October 2022
Language(s):
English
Format:
Text
Subject(s):
Biological Products
Drug Development -- legislation & jurisprudence
Government Regulation
Leukemia, Myeloid, Acute -- drug therapy
United States
United States. Food and Drug Administration
Genre(s):
Guideline
Technical Report
Abstract:
The purpose of this guidance is to assist sponsors in the clinical development of drugs and biological products for the treatment of acute myeloid leukemia (AML). Specifically, this guidance addresses FDA’s current thinking regarding the overall development program and clinical trial designs for the development of drugs to support an indication of treatment of AML, including indications limited to an individual phase of treatment (e.g., maintenance, transplantation preparative regimen, etc.). The contents of this document do not have the force and effect of law and are not meant to bind the public in any way, unless specifically incorporated into a contract. This document is intended only to provide clarity to the public regarding existing requirements under the law. FDA guidance documents, including this guidance, should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidance 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 (34 pages))
NLM Unique ID:
9918504488506676 (See catalog record)
Permanent Link:
http://resource.nlm.nih.gov/9918504488506676