This is a preview of subscription content, log in to check access.
Buy single article
Instant unlimited access to the full article PDF.
Price includes VAT for USA
Subscribe to journal
Immediate online access to all issues from 2019. Subscription will auto renew annually.
This is the net price. Taxes to be calculated in checkout.
Baghdadi R. FDA considering “super offce” of drug safety within drug center. RPM Report, March 25, 2011; http://therpmreport.com/Free/9ac0ed7b-3afe-4fe3-b04c-ced675140264.aspx?utm_source=RPMel.
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.
Goldberg NH, Schneeweiss S, Kowal MK, Gagne JJ. Availability of comparative effcacy 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.
Jenkins J. A United States regulator’s perspective on risk-beneft considerations. FDA presentation, April 23, 2010; http://www.fda.gov/downloads/AboutFDA/CentersOffices/CDER/UCM210155.pdf.
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.
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.
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.
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/.
About this article
Cite this article
Doyle, J.J. Commentary: The Real-world Convergence of Comparative Effectiveness Research and Risk-Beneft Assessment. Ther Innov Regul Sci 45, 691–696 (2011). https://doi.org/10.1177/009286151104500502