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Tag Archives: cell therapy
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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FDA Guidances – November 2010
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 November 2010 (links go directly to PDF documents).
Posted in FDA, Regulatory Strategy
Tagged Cato Research, cell therapy, clinical trials, eCTD, FDA, guidance, in vitro diagnostics, medical devices
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DIA 2010 – Week in Review
The DIA 2010 Annual Meeting was a great success and Washington, DC was a great location. In addition to the thousands of industry attendees, the location made it possible for this year’s meeting to include FDA representatives from all areas … Continue reading
Posted in Conferences and Meetings, eCTD, FDA
Tagged adverse events, biomarkers, biotech, cell therapy, clinical development, clinical trials, CMC, comparative effectiveness, data standards, DIA, eCTD, FDA, globalization, in vitro diagnostics, personalized medicine, pharmacokinetics, Phase 1, Phase 2, RPS, study tagging files, transparency
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