FDA changes NDA letters

August 2008
Pharmaceutical Representative;Aug2008, Vol. 38 Issue 8, p12
The article reports on the new regulations proposed by the U.S. Food and Drug Administration (FDA) in response to concerns expressed by pharmaceutical companies regarding the disapproval of new-drug applications. The new regulations help the FDA adopt a more consistent and neutral way of conveying information to companies. Moreover, FDA emphasizes that drug companies are worried that non-approved letters could have a negative impact on efforts to raise capital.


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