Regulatory News In Brief
This article was originally published in The Gray Sheet
FDA issues documents on advisory committee financial conflicts and scientific integrity. More regulatory updates.
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A voluntary new FDA program aims to relieve the inspectional load on manufacturers and the agency. But some device companies are skeptical that anyone will participate.
FDA plans to publicly issue its staff manual on scientific integrity in the near future.
Device companies may be able to put off an FDA facility inspection if the plant has recently satisfied international quality system standards, according to a 1draft guidance released by the agency May 20