Abstract
Get full access to this article
View all access options for this article.
References
1.
Baghdadi
R.
FDA considering “super office” of drug safety within drug center . RPM Report , March 25, 2011 ; http://therpmreport.com/Free/9ac0ed7b-3afe-4fe3-b04c-ced675140264.aspx?utm_source=RPMel.
2.
Eastman
P.
ODAC backs FDA's strong stance on need for post-marketing studies on accelerated-approval cancer drugs . Oncology Times. February 11, 2011 ; http://journals.lww.com/oncology-times/Fulltext/2011/02250/ODAC_Backs_FDA_s_Strong_Stance_on_Need_for.3.aspx.
3.
Goldberg
NH
Schneeweiss
S
Kowal
MK
Gagne
JJ
. Availability of comparative efficacy data at the time of drug approval in the United States . JAMA.
2011 ; 305 :1786 –1789 ; http://jama.ama-assn.org/content/305/17/1786.short.
4.
Jenkins
J.
A United States regulator's perspective on risk-benefit considerations . FDA presentation, April 23, 2010 ; http://www.fda.gov/downloads/AboutFDA/CentersOffices/CDER/UCM210155.pdf.
5.
Slotnik
J.
CMS-FDA proposed premarket parallel review—the devil is in the details . Value-Based Cancer Care; http://valuebasedcancer.com/article/cms-fda-proposed-premarket-parallel-review%E2%80%94-devil-details.
6.Memorandum of understanding between United States Food and Drug Administration and Centers for Medicare and Medicaid Services . Fed Register.
48699 , August 11, 2010 ; http://www.federalregister.gov/articles/2010/09/17/2010-23252/parallel-review-of-medical-products.
7.
Chambers
JD
Neumann
PJ
. Listening to Provenge—what a costly cancer treatment says about future Medicare policy . NEJM. May 5, 2011 ; http://www.nejm.org/doi/full/10.1056/NEJMp1103057.
8.
Pollack
A.
Medicare will pay for prostate drug . New York Times , June 30, 2011 ; http://prescriptions.blogs.nytimes.com/2011/06/30/medicare-will-pay-for-prostate-cancer-drug/.