Drug Regulatory Affairs

Abstract

The timely and efficient execution of the U.S. Army Medical Materiel Pharmaceutical Development Program requires a thorough knowledge of regulations issued by the U.S. Food and Drug Administration. In order to accomplish the execution of this drug development program, the Pharmaceutical System Project Management Office, an element of the U.S. Army Medical Materiel Development Activity (USAMMDA), awarded a multi-year contract to Engineering and Economics Research (ORIC). The EER/ORIC team has provided the necessary managerial and technical expertise to complete the preparation and assembly of IND/NDAs. A total of six modifications to existing tasks were submitted to the contractor during the fourth contract year. For the duration of the contract, 18 task orders and 21 task order modifications were submitted to the contractor. All task orders were completed or are in progress within the project delivery schedule and cost estimate. Keywords: RA 1 and 5, Pharmaceutical, Regulatory, FDA, ORIC, IND/NDA, USAMMDA.

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Document Details

Document Type
Technical Report
Publication Date
Apr 30, 1990
Accession Number
ADA223865

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  • Arthur M. Horowitz

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