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Tag Archives: inspections
OIG Report Shows Increasing Use of Foreign Clinical Trials in Marketing Applications (and Challenges for the FDA)
There are no foreign lands. It is the traveler only who is foreign. – Robert Louis Stevenson Global. That’s one of the buzz words/ideas that has gripped modern drug development. In particular, there is a notion that foreign countries represent … Continue reading
Posted in Clinical Trials, FDA, Industry News
Tagged biologics, BLA, clinical trials, drug development, FDA, GCP, IND, inspections, marketing application, NDA
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Free Webinar – Planning for FDA Clinical Site Inspections
Join Cato Research for a free educational webinar on Thursday 29 April 2010 at 2PM EST. Cato Research Regulatory Scientist Cathy Anderson will be presenting “Planning for FDA Clinical Site Inspections: Are You at Risk?” Topics covered will include: Responsibilities … Continue reading
