##  [GDUFA & PDUFA Guidelines](/index%2Ephp/regulatory-radio/gdufa-pdufa-guidelines) 

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##### Episode 2

## GDUFA & PDUFA Guidelines

Establishment of the GDUFA and PDUFA guidelines and their impact on innovators and generics. Our experts discuss various merits of the guidelines and the significant changes signed into the law with each latest amendment.







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