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The FDA is looking to shed light on the sometimes murky rules governing compounding operations to distinguish heavily regulated outsourcing facilities from tiny compounding operations that are lightly regulated. Read More
A fiscal 2017 agricultural appropriations bill that breezed through its first congressional hurdle Wednesday proposes a slight funding increase for the FDA, but is still well below the agency’s funding request. Read More
The FDA and the National Institutes of Health are seeking comments on a new draft clinical trial protocol template for NIH-funded investigators. Read More
The FDA is clarifying that if an institutional review board is found to be noncompliant, the FDA may require the IRB to withhold approval of new clinical studies, stop enrolling new subjects in ongoing studies and terminate ongoing studies. Read More
The FDA issued a complete response letter for Newron Pharmaceuticals’ Parkinson’s disease adjunctive therapy Xadago, requesting clinical evaluations of abuse liability and dependency. Read More