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Home » PhRMA TO FDA: SCRAP PART 11, RELY ON LEGISLATION FOR eRECORDS POLICY
PhRMA TO FDA: SCRAP PART 11, RELY ON LEGISLATION FOR eRECORDS POLICY
July 16, 2004
The FDA should abbreviate or even withdraw 21 CFR Part 11 and instead rely on legislative measures passed by Congress to craft policy defining how drugmakers use erecords and esignatures in drug applications, biologics license submissions and other filings with the agency, according to a drug industry trade group.