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FDA has received nine electronic ANDAs submissions, fewer than expected.

This article was originally published in The Tan Sheet

Executive Summary

NINE ELECTRONIC ANDA SUBMISSIONS TO FDA RECEIVED during the first 15 months of the agency's computerized review program for generic drugs. The submissions came from five different companies, Office of Generic Drugs Director Douglas Sporn told a Generic Pharmaceutical Industry Association meeting in New York City March 13. FDA began accepting electronic bioequivalence data filings in January 1997.
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