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  1. Drug Safety and Availability

FDA Expands CDER NextGen Portal

[10/3/2022] FDA is announcing the expansion of the CDER NextGen Portal to enable certain electronic over-the-counter (OTC) monograph submissions to FDA under section 505G of the Federal Food, Drug, and Cosmetic Act. Requests for formal meetings between FDA and sponsors and requestors of OTC monograph drugs and related meeting correspondence (e.g., meeting packages) should now be submitted via the CDER NextGen Portal.   

The benefits of utilizing the CDER NextGen Portal for the submission of requests for formal meetings involving OTC monograph drugs and related meeting correspondence include: 

  • Efficiency: All information regarding meeting requests is stored in one place 
  • Timeliness: Electronic meeting requests can be delivered immediately 
  • Automated confirmation: Sponsors/requestors can log in, initiate a submission, and receive an automated confirmation of a submission 
  • Historical record: Sponsors/requestors can view all of their submissions at any time 

In the future, FDA intends to further develop the CDER NextGen Portal to enable sponsors and requestors to submit other OTC monograph submissions via the CDER NextGen Portal including OTC monograph order requests (OMORs), formal dispute resolution requests related to a final administrative order, administrative hearing requests related to a final administrative order, and responses to record requests by FDA relating to minor changes. FDA intends to inform stakeholders about the expansion of CDER NextGen to enable additional OTC monograph submissions as these updates occur. 

 
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