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Food and drug administration expanded access to treatment†
Implications for oncology patients
Article first published online: 20 APR 2007
Copyright © 2007 American Cancer Society
Volume 109, Issue 11, pages 2157–2160, 1 June 2007
How to Cite
Freedman, R. S. and Markman, M. (2007), Food and drug administration expanded access to treatment. Cancer, 109: 2157–2160. doi: 10.1002/cncr.22681
On December 14, 2006, the U.S. Food and Drug Administration (FDA) issued for comment a proposal to amend their regulations on expanded access to investigational new drugs (INDs) and provided guidance on the application process. Simultaneously, the FDA issued a proposal to clarify and broaden the charging regulations for INDs and for commercially available drugs utilized in those studies for which these drugs do not yet have an approved indication.1, 2
- Issue published online: 18 MAY 2007
- Article first published online: 20 APR 2007
- Manuscript Accepted: 20 FEB 2007
- Manuscript Received: 6 FEB 2007
- 1Department of Health and Human Services, Food and Drug Administration. Expanded access to investigational drugs for treatment use. Docket no. 2006N-0062. Fed Reg. 2006; 71: 75147–75168.
- 2Department of Health and Human Services, Food and Drug Administration. Charging for investigational drugs. Docket no. 2006N-0061. Fed Reg. 2006; 71: 75168–75181.