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US Generic Drug User Fee

Assessing User Fees Under the Generic Drug User Fee Amendments of 2017

This guidance provides stakeholders information regarding FDA’s implementation of the Generic Drug User Fee Amendments of 2017 (GDUFA II) under Title III of the FDA Reauthorization Act of 2017. Because GDUFA II created changes to the user fee program, this guidance serves to provide an explanation about the new fee structure and types of fees for which entities are responsible.

This guidance describes the types of user fees authorized by GDUFA II, the process for submitting payments to FDA, the consequences for failing to pay generic drug user fees, and the process for requesting a reconsideration of a user fee assessment.  This guidance also describes how FDA determines affiliation for purposes of assessing generic drug user fees.  FDA will issue separate guidance documents regarding GDUFA II non-user fee requirements and processes.  This guidance does not address how FDA determines and adjusts fees for each fiscal year.. [FDA]

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US frets over pharma supply chain security

The pandemic highlighted how fragile the global manufacturing network is, as supply of certain products...

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US FDA - Non-Penicillin Beta-Lactam Drugs: A CGMP Framework for Preventing Cross-Contamination

Draft guidance - Submit Comments by 08/23/2022 This guidance describes methods, facility design...

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Grindeks amplia la gamma dei generici

Grindeks, azienda farmaceutica degli Stati baltici le cui principali attività sono la ricerca,...

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FDA Scorecard: Drug Shortages and Inspections

How has the FDA performed in mitigating drug shortages and in its inspection activity since the COVID-19...

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