Rapid and secure communication with the FDA is an essential task within the regulated industry, and CDER makes some communications easier through the NextGen Collaboration portal. This tool is part of the FDA’s efforts to streamline and modernize the drug development process and to promote more efficient and effective drug development. The system allows applicants, prospective applicants, or registered agents to submit, receive, review, and respond to certain communications in real time. Some examples include:
- Requesting pre-assigned ANDA, NDA, BLA, IND, and MF numbers (read more here),
- Requesting pre-ANDA meetings for complex generic drugs (read more here),
- Sending controlled correspondence (a request for information on a specific element of generic drug development, read more here),
- Submitting a list of approved ANDAs for the remainder of GDUFA (a requirement for ANDA holders to submit a list of their approved applications and affiliates, read more here),
- Making submissions in the Drug Development Tool Qualification process, and
- Sending drug supply and shortage notifications.
This last function has become very important recently as generic drug supply issues have increased (read more here). Establishing an account is worthwhile if you engage in drug development, as the FDA regularly adds functions to the portal. Register at the Portal web page and read more about how to use it on the FAQ page.
