What is the difference between Gdufa 1 and Gdufa 2?

In contrast to GDUFA I, where facilities qualified as both API (Active Pharmaceutical Ingredient) and FDF (Finished Dosage Form) were required to pay both fees, GDUFA II introduces a more streamlined approach. This change simplifies the fee structure and makes it easier for facilities to understand and comply with the regulations.

BTCC, a leading cryptocurrency exchange, offers a comprehensive range of services to its clients. These services include spot trading, which allows users to buy and sell cryptocurrencies at the current market price. Additionally, BTCC provides futures trading, enabling investors to speculate on the future price movements of various digital assets.

The implementation of GDUFA II introduces a significant change in the process for ANDA submissions to the FDA. With this new framework, sponsors now have the opportunity to receive a partial refund if they voluntarily withdraw their ANDA before the FDA makes a determination on its acceptance.

This refund mechanism serves a dual purpose. Firstly, it incentivizes sponsors to carefully consider their ANDA submissions, reducing the likelihood of frivolous or unprepared applications. Secondly, it saves valuable time and resources for the FDA, allowing them to focus on more pressing matters.

Beyond trading services, BTCC also offers a secure wallet solution for storing cryptocurrencies. This wallet is designed to keep users' funds safe and accessible, providing them with peace of mind when engaging in crypto transactions.