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Two CDRH officials say that a new final rule on using symbols in medical device labeling gives manufacturers more options.[ Price : $8.95]
Five stakeholders provide comments and suggestions to FDA on a draft guidance on quality metrics technical conformance.[ Price : $8.95]
Duke Universitys National Evaluation System for health Technology says its new coordinating center is to implement a national syst...[ Price : $8.95]
Researchers say they are concerned about the number of FDA medical reviewers who leave the agency to work for industry.[ Price : $8.95]
Federal Register Notice: FDA determines that 4,835 days is the regulatory review period for a Medicines Company NDA for Ionsys (fe...[ Price : $8.95]
Three senators ask the Justice Department to investigate whether Mylan deliberately misclassified its EpiPen as a non-innovator dr...[ Price : $8.95]
A one-year study by Chinese drug regulators finds massive fabrication of clinical trials data for drugs awaiting marketing approva...[ Price : $8.95]
FDA and Athersys reach agreement on a special protocol assessment for the design and planned analysis of a Phase 3 clinical trial ...