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Documents by Lawyers at this office
European Medicines Agency Jeopardizes Investments in Drug Development
Jonathan Berman,Brian J. Forsatz Ph.D.,Christian B. Fulda,Mark D. Kafka,Yasunobu Takatama, December 28, 2012
The heart of a marketing authorization application ("MAA") is the pre-clinical and clinical data that proves the drug's safety and efficacy. This data is collected through substantial investments in time and money. The current and proposed policies of the European Medicines Agency...
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