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FDA To ANDA Sponsors: Don't Forget Quality When Rushing For 10-Month Review Goal

 
• By Derrick Gingery

Agency discusses potential bolus of applications in new fiscal year.

FDA warned again that application quality will be important as it prepares for a potential bolus of ANDAs that could arrive in October when review goals are enhanced again.

The beginning of fiscal year 2017 will mark the zenith of the first cycle of the generic drug user fee...

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More from North America

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How Will Regulatory Filing Winds Blow Globally For Elevidys Following Patient Deaths?

 
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