Simplifying Global Compliance
Articles Tagged with ''FDA''
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.
Promotional materials for Organon's Follistim fertility drug minimized the drug's risks and made unsubstantiated superiority claims, according to an untitled letter released by the FDA late December.
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.
In its first challenge to ban the sale of a dietary supplement under the 1994 Dietary Supplement Health and Education Act (DSHEA), FDA announced Tuesday it will issue a final rule to prohibit the sale of dietary supplements containing ephedra. Read More
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