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Tag Archives: biomarkers
Free Webinar – Optimal Clinical Study Designs and International Regulatory Strategies
Please join us at a joint webinar between the Netherlands Centre for Human Drug Development (CHDR) and Cato Research that addresses current challenges and provides clinical and regulatory strategies to the most expeditious and cost-effective path towards clinical proof of concept and approval. The webinar will be held on Tuesday, 15 November 2011 from 1:00 to 2:00 PM ET. Continue reading
Posted in Clinical Trials, Regulatory Strategy, Webinars
Tagged biomarkers, Cato Research, clinical trials, drug development, EMA, FDA, pharmacodynamics, pharmacokinetics, Phase 1, Phase 2, pivotal studies, regulatory strategy, webinar
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August 2011 FDA Guidances
Here’s a (very lengthy) list of the guidances released by FDA in August 2011, compiled by Cato Research Regulatory Scientist Cathy Anderson. Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring (Draft) Postmarket Surveillance Under Section 522 of the … Continue reading
Conference Recap – Biomarker World Congress 2011
Everywhere in the news today, we hear that we are in the era of personalized medicine – where new medicines will be tailor-made for individual patients. Specifically, personalized medicine is dedicated to the concept hat the right drug is … Continue reading
Posted in Clinical Trials, Conferences and Meetings
Tagged biomarkers, breast cancer, cancer, Chemotherapy, clinical trials, efficacy, oncology, personalized medicine, Phase 1, Phase 2, validation
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Diabetes Research Strategic Plan
The media continually alerts us to the epidemic of diabetes in the world. Diabetes is the seventh leading cause of death. Worldwide in 2007 there were 246 million people diagnosed with diabetes, and an additional 79 million people are at … Continue reading
Posted in Clinical Trials, Industry News
Tagged biomarkers, clinical research, clinical trials, diabetes, guest post, NIH, patient recruitment
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October 2010 FDA Guidances
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 October 2010 (links go directly to PDF documents).
Posted in FDA, Industry News, Regulatory Strategy
Tagged biomarkers, Cato Research, clinical trials, CMC, drug development, FDA, guidance, IND, medical devices, NDA
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