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"Approvable" No More
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Pharmaceutical Executive
- Article date:
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August 1, 2008
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Copyright informationCopyright Advanstar Communications, Inc. Aug 2008. Provided by ProQuest LLC. (Hide copyright information)
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REGULATORY
FDA attempts to clarify its rulings by spelling out the difference between a good drug and a bad drug
A new policy from FDA aims to clear up widespread confusion and uncertainty related to the "approvable" and "non-approvable" letters sent to pharma companies when the agency finds a new drug application deficient. While a "not approvable" letter clearly signalled bad news, and an "approval" letter the holy grail, the "approvable" letter was somewhere in between. Analysts and the media often interpreted "approvable" to mean that final approval was just around the corner, even though the communiqué often meant that companies needed to conduct more research to gain final market ...
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