Drug Regulatory Affairs
Annual rept. 2 Jun 1986-30 Jun 1987
ENGINEERING AND ECONOMICS RESEARCH INC GERMANTOWN MD
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The Pharmaceutical System Project Management Office PSPMO, an element of the U.S. Army Medical Materiel Development Activity USAMMDA holds the responsibility for planning, organizing, directing and controlling all aspects of drug development. Every stage of drug development must be in compliance with current FDA requirements. The principal objective of this contract is to prepare and assemble drug-specific, FDA-related documentation as well as a data management system to track the status of regulatory documentation. This initial Annual Report describes the work performed by the contractor for the 12 months period of June 2, 1986 to June 30, 1987.
- Administration and Management