Drug Bioequivalence Page: 71
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71
appendix
PROCEEDINGS OF THE PANEL
To enable the Office of Technology Assessment (OTA)
to provide the Subcommittee on Health (U.S. Senate
Committee on Labor and Public Welfare) with
recommendations regarding drug product equivalence
and variation, it was necessary to select a group
of representative experts who could review all
pertinent technical information and report their
conclusions within three months.
OTA initiated discussions with several organizations
that might be able to furnish staff support and
carry out other responsibilities to assist the
expert panel in its deliberations. A proposal
from Family Health Care, Inc., Washington, D.C.,
and ensuing negotiations resulted in the award of
a contract to that firm to provide staff assistance
to the panel. With the guidance and approval of
OTA, Dr. Robert Berliner, Dean of the Yale
University School of Medicine was selected as
Chairman of the panel.
Under Dr. Berliner's direction and with OTA
approval, eight additional members and one
ex-officio member (from the OTA Advisory Council)
were selected. A press release on April 11, 1974,
formally announced the study and the formation of
the Drug Bioequivalence Study Panel. The following
is a review of the activities and proceedings of
the Panel.
The first of four planned meetings of the Panel
was convened in Washington, D.C., on April 12. At
this meeting, the Panel discussed the scope of the
study and developed wording to state its inter-
pretation of the charge it had been given. It was
agreed that information regarding bioequivalence
should be obtained from a number of organizations
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United States. Congress. Office of Technology Assessment. Drug Bioequivalence Study Panel. Drug Bioequivalence, report, July 1974; [Washington D.C.]. (https://digital.library.unt.edu/ark:/67531/metadc39335/m1/71/: accessed April 23, 2024), University of North Texas Libraries, UNT Digital Library, https://digital.library.unt.edu; crediting UNT Libraries Government Documents Department.