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Article: Getting SMART: drug review in the computer age. (Submission Management and Review Tracking system provides better records) (includes related article on how to compile information for new drug application)
- Article from:
- FDA Consumer
- Article date:
- October 1, 1995
- Author:
CopyrightCOPYRIGHT 1995 U.S. Government Printing Office. This material is published under license from the publisher through the Gale Group, Farmington Hills, Michigan. All inquiries regarding rights should be directed to the Gale Group. (Hide copyright information)
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The Food and Drug Administration is in the early stages of launching its drug review and approval system into cyberspace. This will transform a process that has traditionally involved laborious hands-on scrutiny of mountains of paper into a computerized system able to accomplish in an instant what now might take hours or days or weeks of tedious checking and rechecking.
And the system will work not just faster, but better. Electronic data handling will let agency reviewers of drugs and biological products spot problems, such as unexpected side effects or subtle variations in drug metabolism, that might be buried in the millions of bits of information that tell ...