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An Integrated Approach to Biosimilar Development & Commercialization
September 29, 2011
As the market for biosimilar products continues to grow, many biopharmaceutical companies trying to enter the space are struggling to overcome the unique challenges that developing such products presents. -
Regulations for Clinical Studies in Pediatric Patients in the European Union
March 10, 2010
After the United States issued pediatric drug study requirements, the European Union (EU) passed a regulation that created major changes to clinical studies for pediatric -
New FDA Guidance on Antidiabetic Therapies
December 11, 2009
Understanding the FDA Guidance on Assessing Cardiovascular Risks for new Antidiabetic Therapies. Learn what FDA cardiac safety requirements may mean for your development program.
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