Healthy Skepticism Library item: 15672

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: Journal Article

Lindstrom JA.
Sources of drug information: FDA-approved labeling and other official FDA sources.
Dermatol Ther. 2009 May-Jun; 22:(3):246-56
http://www3.interscience.wiley.com/resolve/openurl?genre=article&sid=nlm:pubmed&issn=1396-0296&date=2009&volume=22&issue=3&spage=246

Abstract:

To protect the public health and facilitate the safe and effective use of prescription drugs, the Food and Drug Administration (FDA) disseminates information through drug labeling, communication of safety issues, and the archiving of scientific reviews. The content and format requirements for professional labeling were revised in 2006 to improve the accessibility and usability of the information. New or emerging safety information is communicated using the formats of public health advisories (PHAs), information for heath care professional sheets, and early communications about ongoing safety reviews. The FDA analyses of approved drug marketing applications and Advisory Committee transcripts are posted on the FDA Web site. Prescribers can utilize these resources to inform the care that they provide to patients.