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Home » PhRMA WANTS LEGISLATION USED TO CRAFT eRECORDS POLICY
PhRMA WANTS LEGISLATION USED TO CRAFT eRECORDS POLICY
July 23, 2004
A major drug industry trade group has suggested the FDA abbreviate or withdraw 21 CFR Part 11 in favor of existing legislative measures to craft policy defining how drugmakers use erecords and esignatures in drug applications, biologics license submissions and other filings with the agency.