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Opening Pandora's pillbox: using modern information tools to improve drug safety.
Health Aff (Millwood). 2005 Jul-Aug; 24(4):938-48.HA

Abstract

How the Food and Drug Administration (FDA) responds to criticism of its drug safety process will determine whether drug safety actually improves. Propping up the Office of Drug Safety with more bureaucratic prominence or adding new requirements to the preapproval process will add to the cost of drug development and not make drugs safer. New information tools can dramatically improve postmarketing surveillance and collection of data on safety. This information could then be used to reach more definitive regulatory conclusions sooner. New incentives will be needed to entice payers and product developers to work on building a broader, more robust system for collecting data on drug safety.

Authors+Show Affiliations

American Enterprise Institute in Washington, DC, USA. Scott.Gottlieb@mssm.edu

Pub Type(s)

Journal Article

Language

eng

PubMed ID

16012136

Citation

Gottlieb, Scott. "Opening Pandora's Pillbox: Using Modern Information Tools to Improve Drug Safety." Health Affairs (Project Hope), vol. 24, no. 4, 2005, pp. 938-48.
Gottlieb S. Opening Pandora's pillbox: using modern information tools to improve drug safety. Health Aff (Millwood). 2005;24(4):938-48.
Gottlieb, S. (2005). Opening Pandora's pillbox: using modern information tools to improve drug safety. Health Affairs (Project Hope), 24(4), 938-48.
Gottlieb S. Opening Pandora's Pillbox: Using Modern Information Tools to Improve Drug Safety. Health Aff (Millwood). 2005 Jul-Aug;24(4):938-48. PubMed PMID: 16012136.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Opening Pandora's pillbox: using modern information tools to improve drug safety. A1 - Gottlieb,Scott, PY - 2005/7/14/pubmed PY - 2005/12/16/medline PY - 2005/7/14/entrez SP - 938 EP - 48 JF - Health affairs (Project Hope) JO - Health Aff (Millwood) VL - 24 IS - 4 N2 - How the Food and Drug Administration (FDA) responds to criticism of its drug safety process will determine whether drug safety actually improves. Propping up the Office of Drug Safety with more bureaucratic prominence or adding new requirements to the preapproval process will add to the cost of drug development and not make drugs safer. New information tools can dramatically improve postmarketing surveillance and collection of data on safety. This information could then be used to reach more definitive regulatory conclusions sooner. New incentives will be needed to entice payers and product developers to work on building a broader, more robust system for collecting data on drug safety. SN - 0278-2715 UR - https://www.unboundmedicine.com/medline/citation/16012136/Opening_Pandora's_pillbox:_using_modern_information_tools_to_improve_drug_safety_ L2 - http://www.healthaffairs.org/doi/full/10.1377/hlthaff.24.4.938?url_ver=Z39.88-2003&rfr_id=ori:rid:crossref.org&rfr_dat=cr_pub=pubmed DB - PRIME DP - Unbound Medicine ER -