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Home » FDA CONSIDERS PART 11 RULE REVISIONS, SEEKS INDUSTRY COMMENT
FDA CONSIDERS PART 11 RULE REVISIONS, SEEKS INDUSTRY COMMENT
April 14, 2004
The FDA has broken its silence on Part 11 for the first time since issuing a guidance last August by calling on industry to comment on how to make Part 11 "less prescriptive," either by revising the rule or issuing additional guidance documents.