Improving the Effectiveness of FDA Drug Inspection

The evaluation and the allocation of inspection resources is a problem faced by private sector firms as well as by several government agencies. This paper reports the development and the use by the Food and Drug Administration (FDA) of decision making tools for measuring the performance of their dru...

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Vydané v:Operations research Ročník 40; číslo 5; s. 845 - 855
Hlavní autori: Klimberg, Ronald, Revelle, Charles, Cohon, Jared
Médium: Journal Article
Jazyk:English
Vydavateľské údaje: Linthicum, MD INFORMS 01.09.1992
Operations Research Society of America
Institute for Operations Research and the Management Sciences
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ISSN:0030-364X, 1526-5463
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Abstract The evaluation and the allocation of inspection resources is a problem faced by private sector firms as well as by several government agencies. This paper reports the development and the use by the Food and Drug Administration (FDA) of decision making tools for measuring the performance of their drug inspection activities in which data are collected only intermittently, and a multiobjective integer program to assist FDA decision makers in planning and evaluating the effectiveness of their drug inspection activities.
AbstractList The evaluation and the allocation of inspection resources is a problem faced by private sector firms as well as by several government agencies. This paper reports the development and the use by the Food and Drug Administration (FDA) of decision making tools for measuring the performance of their drug inspection activities in which data are collected only intermittently, and a multiobjective integer program to assist FDA decision makers in planning and evaluating the effectiveness of their drug inspection activities.
The Food and Drug Administration (FDA) is the federal agency responsible for regulating the pharmaceutical industry. With its limited resources, the FDA intermittently inspects approximately 4,000 firms and collects and analyzes thousands of drug products. Several analytical tools have been developed to assist FDA management in the planning and evaluation of its drug inspection program. Analytical tools have been developed to produce unbiased performance measurements for the entire industry. A multiple objective integer programming model was developed to determine how to allocate FDA drug inspection resources. As a result, a trade-off curve is generated that illustrates the relationship between the expected number of violations to be detected and the resources to be used for the entire range of alternatives. Altogether, these decision-making tools have been implemented successfully by the FDA as part of its surveillance of the pharmaceutical industry.
Author Cohon, Jared
Klimberg, Ronald
Revelle, Charles
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CitedBy_id crossref_primary_10_1007_s11518_018_5382_8
crossref_primary_10_1016_j_cie_2017_07_009
crossref_primary_10_1016_0038_0121_94_90001_9
crossref_primary_10_2139_ssrn_2709881
crossref_primary_10_1287_mnsc_2020_3889
crossref_primary_10_1016_j_cie_2018_04_022
ContentType Journal Article
Copyright Copyright 1992 The Operations Research Society of America
1993 INIST-CNRS
Copyright Institute for Operations Research and the Management Sciences Sep/Oct 1992
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The Food and Drug Administration (FDA) is the federal agency responsible for regulating the pharmaceutical industry. With its limited resources, the FDA...
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SubjectTerms agencies: regulating inspections
Biological and medical sciences
Case studies
data analysis: multiple logistic regression and index
decomposed and heuristics
Drug design
Drug regulation
Federal regulation
government
Government agencies
Health and social institutions
Heuristics
Industrial regulation
Inspections
Integer programming
Mathematical models
Medical sciences
Medication adherence
multiple criteria: multiobjective integer program
OR Practice
Pharmaceutical industries
Pharmaceutical industry
Probabilities
programming
Public health. Hygiene
Public health. Hygiene-occupational medicine
Statistics
Surveillance
Tradeoffs
Title Improving the Effectiveness of FDA Drug Inspection
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