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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 Office of Generic Drugs had a banner year in 2015, seeing more than 700 full and tentative approvals, the agency announced yesterday in its first-ever report on generics. Read More
It took a few days and a threatened contempt of Congress citation, but Valeant Pharmaceuticals International’s CEO J. Michael Pearson has agreed to meet with Senate officials investigating rising prescription drug prices. Read More
How much training do clinical investigators and clinical study staff need to stay up to date on good clinical practices, particularly to ensure compliance for multiregional clinical trials? In a recent study, the Clinical Trials Transformation Initiative evaluated the content, frequency, format and enrollment evidence of GCP training and provided recommendations to improve the efficiency of GCP training. Jonathan Seltzer, the director of clinical research at the Lankenau Heart Institute and a co-author of the study, “Good Clinical Practice Training: Identifying Key Elements and Strategies for Increasing Training Efficiency,” talks with CTA about the findings.Read More
Sanofi and Regeneron Pharmaceuticals said their rheumatoid arthritis treatment sarilumab demonstrated superiority over AbbVie’s blockbuster Humira in a Phase 3 Study. 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