Regulatory News In Brief
This article was originally published in The Gray Sheet
FDA released a final rule on protections for children in clinical trials and a final guidance on financial disclosures by investigators. More regulatory news.
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Regulatory Roundup: St. Jude Resolves Warning Letter; DePuy Synthes Recall; Syphilis Screening Guidance
St. Jude Medical resolves neuromodulation device facility warning letter; Depuy Synthes craniomaxillofacial distraction system recall tapped as class I; FDA recommends syphilis screening test policies.
FDA issues guidance documents on PMA and 510(k) user fees and refunds. Agency issues proposed order for three pre-amendment devices. More regulatory news.
Final guidance on drug sponsors’ responsibilities for financial disclosures related to clinical investigators who participate revises definitions of due diligence and covered clinical studies from the draft published in 2011, but retains FDA’s statement that it may include such disclosures in the documents released upon product approval for marketing.