Accelerated approval and possible withdrawal of midodrine

JAMA

Volumn 304, Issue 19, 2010, Pages 2172-2173

  Dhruva, Sanket S ^a   Redberg, Rita F ^a  

^a UNIVERSITY OF CALIFORNIA   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ALPHA 1 ADRENERGIC RECEPTOR STIMULATING AGENT; MIDODRINE;

DECISION MAKING; DRUG APPROVAL; DRUG INDUSTRY; DRUG MARKETING; FOOD AND DRUG ADMINISTRATION; HUMAN; NOTE; ORTHOSTATIC HYPOTENSION; POSTMARKETING SURVEILLANCE; PRIORITY JOURNAL; SYSTOLIC BLOOD PRESSURE; TREATMENT OUTCOME; UNITED STATES;

EID: 78349262667     PISSN: 00987484     EISSN: 15383598     Source Type: Journal    
DOI: 10.1001/jama.2010.1695     Document Type: Note

References (10)

1. US Government Accountability Office. New drug approval: FDA needs to enhance its oversight of drugs approved on the basis of surrogate endpoints: Government Accountability Office, September 23, 2009. http://www.gao.gov/ products/GAO-09-866. Accessed September 21, 2010.
2. US Food and Drug Administration. FDA proposes withdrawal of low blood pressure drug: companies failed to provide evidence of clinical benefit of midodrine hydrochloride, August 16, 2010. http://www.fda.gov/NewsEvents/ Newsroom/PressAnnouncements/ucm222580.htm. Accessed September 21, 2010.
3. US Food and Drug Administration. Midodrine update: September 10, 2010. http://www.fda.gov/Drugs/DrugSafety/ucm225444.htm. Accessed September 21, 2010.
4. Temple R. Are surrogate markers adequate to assess cardiovascular disease drugs? JAMA. 1999;282(8):790-795.
5. US Food and Drug Administration. CFR - Code of Federal Regulations, title 21, volume 5; revised April 1, 2010. http://www.accessdata.fda.gov/scripts/ cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=314&showFR=1&subpartNode=21:5.0. 1.1.4.8. Accessed September 21, 2010.
6. Harris G. FDA backtracks and returns drug to market. New York Times. September 3, 2010. http://www.nytimes.com/2010/09/04/health/policy/04fda.html. Accessed September 24, 2010.
7. Nainggolan L. FDA does U-turn on midodrine: will keep it available. Heartwire Clinical Cardiology Web site. http://www.theheart.org/article/1119697. do. Accessed September 21, 2010.
8. Fleming TR. Surrogate endpoints and FDA's accelerated approval process: the challenges are greater than they seem. Health Aff (Millwood). 2005;24(1):67-78.
9. Pollack A. FDA postpones rule on breast cancer drug. New York Times. September 17, 2010. http://prescriptions.blogs.nytimes.com/2010/09/17/f-d-a- postpones-rule-on-breast-cancer-drug/. Accessed October 24, 2010.
10. Genentech. Genentech provides update on avastin for advanced breast cancer: September 17, 2010. http://www.gene.com/gene/news/press-releases/ display.do?method=detail&id=12967. Accessed September 21, 2010.