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Tag Archives: REMS
New FDA Guidances – February 2011
Each month, Cato Research Regulatory Scientist Cathy Anderson compiles a list of the notable guidance documents released by the FDA. Here’s a summary of the guidances released in February 2011 (links go directly to PDF documents). Clinical Pharmacogenomics: Premarketing Evaluation … Continue reading
Posted in Clinical Trials, FDA, Industry News, Regulatory Strategy
Tagged ANDA, cell therapy, clinical trials, FDA, guidance, NDA, REMS, safety
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Joint Statistical Meetings 2010 Retrospective: A CRO Statistician’s Perspective
Image via Wikipedia The Joint Statistical Meetings is often a good place to learn about emerging issues in the analysis of clinical trials (and all of the other fields that statistics touches, as a matter of fact). Here are just a … Continue reading
Free Webinar – Past, Present and Future of REMS: Can We Mitigate With Restraint?
Join Cato Research for a free educational webinar on Thursday, 24 June 2010 at 2:00 PM ET. The webinar, titled Past, Present and Future of REMS: Can We Mitigate With Restraint?, will be presented by Jack Snyder, M.D., J.D., Ph.D., … Continue reading
