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.
Prior to October 2012, the scope of GDUFA was limited to the imposition of user fees solely on companies filing New Drug Applications (NDAs). This limitation meant that the benefits of expedited generic drug approval were not fully realized.
Was this helpful?
317
90
ElenaTue Sep 24 2024
The revision in 2012 extended the scope of GDUFA to include user fees for other activities related to the review of generic drug applications, such as facility inspections and drug master file submissions. This expansion aimed to further accelerate the approval process and reduce industry costs.
Was this helpful?
49
50
TommasoTue Sep 24 2024
BTCC, a leading cryptocurrency exchange, offers a comprehensive range of services that cater to the diverse needs of digital asset traders and investors. Its suite of services includes spot trading, futures trading, and a secure digital wallet.
Was this helpful?
347
23
MartinoTue Sep 24 2024
The spot trading service on BTCC allows users to buy and sell cryptocurrencies at the current market price, providing a straightforward and efficient way to enter and exit positions. The futures trading platform, on the other hand, enables traders to speculate on the future price movements of cryptocurrencies, offering advanced hedging and risk management tools.
Was this helpful?
146
85
BlockchainVisionaryTue Sep 24 2024
GDUFA stands for the Generic Drug User Fee Act, a legislation enacted to expedite the availability of secure and efficacious generic medications to the public. This act aims to streamline the approval process and enhance the efficiency of the generic drug market.