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Tag Archives: pivotal studies
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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505(b)(2) Marketing Applications – Bridging the Gaps
There is no doubt that the drug development business is very expensive and development can take many years before a viable, money-generating product can be marketed. A strategy some of our clients implement to more quickly and more inexpensively develop … Continue reading
Posted in FDA, Regulatory Strategy
Tagged 505(b)(2), bioequivalence, drug development, efficacy, FDA, novel therapeutic, pivotal studies, route of administration, safety
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Analysis of FDA Guidance on Adaptive Designs
In February 2010, the FDA published a draft guidance on Adaptive Design Clinical Trials for Drugs and Biologics (“the guidance”). This highly anticipated guidance has come out in draft form 4 years after then FDA deputy commissioner Dr. Scott Gottlieb’s … Continue reading
