What is a Gdufa fee?
I'm curious to know more about the Gdufa fee. Could you please explain what it is and what it entails? Is it a type of regulatory fee associated with the pharmaceutical industry? If so, how does it affect companies that are looking to bring new drugs to market? I'd appreciate any insight you can provide on this topic.
What is the difference between Pdufa and Gdufa?
Could you please elaborate on the distinction between PDUFA and GDUFA? As both relate to the pharmaceutical industry, I'm curious to understand how they differ in terms of their purpose, scope, and potential impact on drug development and approval processes. Specifically, what are the key differences in their objectives, the agencies they involve, and the types of drugs they primarily focus on?