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CDER Update May/June 2017

·         Activities Report of the Generic Drug Program (FY 2017) 

 

 

·         Office of Pharmaceutical Quality - Emerging Technology Program promotes the adoption of innovative approaches to pharmaceutical manufacturing.

 

 

 

This guidance describes the process through which prospective generic drug applicants submit pre-submission facility correspondence (PFC) in advance of priority generic drug submissions.

 

 

 

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