Regulatory News In Brief
This article was originally published in The Gray Sheet
Executive Summary
New guidance, rules and more from FDA and Congress.
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Regulatory Briefs: Reclassification Of Scleral Plug; Radiation Dose Standards
FDA reclassifies scleral plug, a pre-amendment ophthalmic device, from class III to class II with special controls. The Medical Imaging & Technology Alliance publishes its fourth standard to optimize radiation dose exposure.
Regulatory News In Brief
FDA issues final rule on good manufacturing practices for combination products. Rule withdrawn on scientific misconduct policy. More regulatory news.
Regulatory News In Brief
Physician Payment Sunshine Act finally goes to OMB. FDA signs regulatory agreements with Brazil, Australia and Canada. More regulatory news.