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Searching Content indexed under Consumer Protection by T. Reed Stephens ordered by Published Date Descending.
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FDA Issues Draft Guidance, Requests Public Comments On Communication Of Off-Label Information
The U.S. Food and Drug Administration is evaluating its policies regarding the communication of off-label information for drugs, biologics and devices, with the issuance of a draft guidance and the opening of a docket for public comments.
United States
10 Jan 2012
2
Third Circuit Decides Long-Awaited Antidepressant Drug Labeling Preemption Cases
Manufacturers of antidepressant drugs are shielded from state failure-to-warn liability on the unique facts of FDAs repeated, intensive and public oversight of antidepressant drug labeling; questions about the scope of FDA preemption in broader contexts remain open.
United States
23 Apr 2008
3
FDA Issues Proposed Regulations On Supplemental Applications For Labeling Changes
Proposed Rules would codify FDAs long-standing view underscoring the circumstances that justify unilateral changes to labeling by the holder of the approved application.
United States
28 Jan 2008
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