The US FDA is providing more details on the kinds of information that firms can communicate about their products that would be consistent with FDA-required labeling in a final guidance.
'Off-Label' Communications That Are Still 'Consistent' With Labeling Get Better Defined
US FDA's final guidance provides more examples of data that meets the 'scientifically appropriate and statistically sound' standard.
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Product reviews for drugs, biologics, devices, tobacco and foods could be consolidated into one office at the FDA, as part of a restructuring plan circulating that was obtained by Pink Sheet.
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Pink Sheet reporter and editors discuss how the massive layoffs will reshape the FDA and its impact on the drug and biologics industries.
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Former Acting FDA Commissioner Sara Brenner is said to have asked Tracy Beth Høeg, new special assistant to the commissioner, to help reexamine the application. Høeg’s position at the agency is raising concerns about the FDA's ongoing approach to vaccine regulation.
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The departure data emerged along with a Health and Human Services Department memo describing conceptual plans to consolidate and restructure offices at the FDA and other agencies.