This Article  • Full text  • PDF  • Send to a friend  • Save in My Folder  • Save to citation manager  • Permissions  Citing Articles  • Citation map  • Citing articles on HighWire  • Contact me when this article is cited  Related Content  • Related article  • Similar articles in JAMA  Topic Collections  • Medical Practice  • Law and Medicine  • Quality of Care  • Patient Safety/ Medical Error  • Drug Therapy  • Adverse Effects  • Drug Therapy, Other  • Alert me on articles by topic  Social Bookmarking   What's this?

Catherine D. DeAngelis, MD, MPH; Phil B. Fontanarosa, MD, MBA

JAMA. 2008;300(16):1939-1941.

	Since this article does not have an abstract, we have provided the first 150 words of the full text and any section headings.

The benefits and risks associated with pharmaceutical agents and medical devices have received increasing attention from the medical community, the public, and government agencies. Serious concerns about US Food and Drug Administration (FDA) capabilities and oversight for ensuring accurate determination of safety and efficacy, appropriate mechanisms and decisions regarding drug and device approval, and effective postmarketing surveillance have prompted investigations by the Institute of Medicine¹ and by an FDA blue ribbon commission.² Major legislation³ has been enacted to improve the agency's ability to fulfill the daunting responsibility of ensuring that pharmaceutical products and medical devices approved for marketing are safe.⁴

Even though the evaluation of new drugs and devices is technically rigorous, the current approach of basing drug approval decisions on clinical trials of efficacy that include relatively small numbers of patients virtually guarantees that the full risks and complete . . . [Full Text of this Article]

Author Affiliations: Dr DeAngelis is Editor in Chief and Dr Fontanarosa (phil.fontanarosa@jama-archives.org) is Executive Deputy Editor, JAMA.

CiteULike    Connotea    Del.icio.us    Digg    Reddit    Technorati     What's this?

RELATED ARTICLE

Safety-Related Regulatory Actions for Biologicals Approved in the United States and the European Union
Thijs J. Giezen, Aukje K. Mantel-Teeuwisse, Sabine M. J. M. Straus, Huub Schellekens, Hubert G. M. Leufkens, and Antoine C. G. Egberts
JAMA. 2008;300(16):1887-1896.
ABSTRACT | FULL TEXT  

THIS ARTICLE HAS BEEN CITED BY OTHER ARTICLES

Regulating the Safety of Pharmaceuticals: The FDA, Preemption, and the Public's Health
Gostin
JAMA 2009;301:2036-2037.
FULL TEXT