Articles Tagged with ''FDA''

EXCEL SPREADSHEETS MUST BE AUTHENTICATED FOR COMPLIANCE

Devicemakers need to conduct authenticity checks on all electronic records and submissions to ensure that the program being used is compliant with 21 CFR Part 11 and all predicate rule requirements, according to a leading Part 11 expert.

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EPHEDRA BAN WILL TEST FDA AUTHORITY UNDER DSHEA

FDA authority will be tested for the first time under the 1994 Dietary Supplement Health and Education Act (DSHEA) in March as the agency girds itself against court challenges from supplement makers when a U.S. ban against ephedra goes into effect.

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