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)

FDA Consumer | October 1, 1995| | Copyright

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 ...

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