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The U.S. Food and Drug Administration plans to tighten restrictions on dozens of spinal screws already on the market, requiring new PMAs for dynamic stabilization systems that are used to treat severe spondylolisthesis, fracture, dislocation, scoliosis and spinal tumors. Read More
Clinical trial sponsors and contract research organizations incur the majority of good clinical practice violations, a European Medicines Agency panel reports. Read More
Indian authorities issued a number of clinical trial regulations last month, covering compensation for trial injuries, exemptions for local Phase III trials and penalties for conducting trials without permission. Read More
Regulators, sponsors and clinical investigators wrestled with trial data transparency and reporting requirements for the second year in a row, with the European Medicines Agency trying to pin down the most effective ways to require sponsors to share the results of their studies. U.S. officials were primarily concerned with stimulating development of new antibiotics, encouraging sponsors and investigators to more deeply analyze subgroup outcomes and promoting the use of biomarkers in drug trials. Read More