SOLICITATION NOTICE
D -- ACCESS TO OUTPATIENT PRESCRIPTION- AND PATIENT-LEVEL DRUG UTILIZATION DATA
- Notice Date
- 3/7/2008
- Notice Type
- Solicitation Notice
- NAICS
- 541990
— All Other Professional, Scientific, and Technical Services
- Contracting Office
- Department of Health and Human Services, Food and Drug Administration, Office of Acquisitions and Grants Services, 5630 Fishers Lane, Room 2129, Rockville, MD, 20857-0001, UNITED STATES
- ZIP Code
- 00000
- Solicitation Number
- FDA-SOL-08-00527
- Archive Date
- 3/14/2008
- Point of Contact
- Sherry Solodkova, Contract Specialist, Phone 301-827-7165, - Ted Weitzman, Contracting Officer , Phone 301-827-7178, Fax 301-827-7101
- E-Mail Address
-
sherry.solodkova@fda.hhs.gov, ted.weitzman@fda.hhs.gov
- Description
- FDA seeks to continue to access drug utilization data in an outpatient setting at the national level in the US. The ability of FDA to respond expeditiously to the increasing number of postmarketing issues is of paramount importance to the overall public safety. Continued access to these data complement and strengthen the utility of the passive reporting system currently in place by providing estimates of the numbers of patients exposed to drugs and the numbers of prescriptions dispensed nationwide in the outpatient setting. These data provide a denominator, or context, for understanding adverse event reports; for modeling drug risk based on usage patterns; and for calculating patient-based reporting rates for drugs used in the outpatient setting. Access to these data also increase the FDA's ability to perform regulatory impact studies; in particular, those studies that assess the impact of risk managements plans and labeling changes on prescribing habits and usage patterns for prescription drugs. Finally, direct access to these data in real time enhances and accelerates the pace of FDA's regulatory decision-making process.
- Record
- SN01526816-W 20080309/080307223536 (fbodaily.com)
- Source
-
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