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Regulatory Affairs News and topics related to marketing laws, regulations and guidelines. Includes news feeds from FDA, including press releases, advisory committee meeting announcements, and drug safety notices.

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Old 28th December 2011, 01:08 PM
Pharma Newshound Pharma Newshound is offline
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Default Court Ruling - If Upheld - Casts Doubt on FDA's Use of Guidance Documents

Source: WLF

A federal court in Florida held recently that the Federal Food and Drug Administration lacked the authority to enjoin the practice of pharmacists filling a veterinarian's prescription for a non-food producing animal by compounding from bulk substances.

How does this endanger FDA's ability to issue guidance documents?

See pdf file attached.
Attached Files
File Type: pdf 12-16-11PalmerGibbs_LegalBackgrounder.pdf (48.4 KB, 106 views)
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