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Quicker ANDA approvals for lower drug costs?
June 2017
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AMSTERDAM—Girish Malhotra, president of EPCOT International and CPhI Worldwide Annual Industry Report member, recently discussed the necessity of time reduction for Abbreviated New Drug Application (ANDA) approvals, arguing that if the current approval time can be reduced from 10 months to three months, drug costs will decrease.
 
Currently, it takes up to four review cycles to approve an ANDA, and the first and foremost challenge is with submission completeness. On average, it takes the FDA reviewing team 45 days to determine application completeness, but Malhotra said this time can potentially be reduced to 15 days if the U.S. Food and Drug Administration modifies its review process, in part if a pre-ANDA program was initiated, along with a first-step quality by analysis implementation in the application filing process. Also, the volume of applications could can be minimized if the FDA went with a streamlined best basis planning scenario strategy, which would also reduce time and cost.

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