Important note: Information in this article was accurate in 1996. The state of the art may have changed since the publication date.
Food and Drug Administration, U.S. Department of Health and Human Services - October 25, 1996
Stephanie Schwalbe; (301) 443-1130
The teams' close cooperation in field inspection and in review of manufacturing and testing protocols made possible the approval for CRIXIVAN«, a protease inhibitor, in 42 days, FDA's fastest approval time for an AIDS therapy.
The Hammer Award is given to employees who have advanced the President's National Performance Review by putting the public citizen first, empowering their employees, and getting back to basics. It was presented to the Baltimore District Office and Merck & Co., Inc. by Robert Stone, head of the Office of the Vice President, National Performance Review.
"The most important performance gauge in the pharmaceutical field is the speed with which important new drugs are determined to be safe and effective, and made available to patients who need them," Stone said at the award ceremony in Elkton, VA. "The approval for CRIXIVAN« set a new standard for AIDS therapies -- drugs whose FDA approval times were already the fastest in the world."
The key element of the speedy approval was the early cooperation of Baltimore District employees, consisting of chemists, investigators and managers, with officials from Merck's Elkton, VA manufacturing facility, to create a plan for reviewing and evaluating manufacturing documentation as soon as it was available. The interactions replaced the usual approach of a single, final, time consuming inspection, and thereby greatly contributed to the expedited approval of this promising new treatment for AIDS.
The award consists of a $6.00 hammer, a ribbon, and a card from Vice President Gore, all in an aluminum frame.
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SOURCE: Food and Drug Administration (FDA).
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