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  4. Drug Development Tool (DDT) Qualification Programs
  5. Drug Development Tool Submissions Process
  1. Drug Development Tool (DDT) Qualification Programs

Drug Development Tool Submissions Process

As part of an ongoing effort to modernize FDA interactions with requestors and facilitate collaborative and innovative drug development tool qualification, CBER and CDER have launched the NextGen Collaboration Portal. It is intended to provide requestors with an easier and more efficient way to receive, manage, and upload DDT submissions. This is a common submission portal for all Drug Development Tools submissions; including those that are CDER-specific, CBER-specific or applicable across both Centers. Please note, there are no fees associated with the DDT Qualification Programs.

Instructions on how to submit regulatory documents (e.g., Letter of Intent, Qualification Plan, Full Qualification Package) to a DDT Qualification Program are described below. If you have multiple DDT development proposals, they should be submitted separately, even if they are related.

Electronic Submissions Only Starting July 23, 2019: Please be advised that we will only be receiving electronic submissions through the NextGen Collaboration Portal. The Portal serves as a central location for making submissions, viewing submission statuses, and reviewing communications from the FDA. Register for an account by following the step by step guide. In addition to submitting to the Portal, please also email your submission materials to CDERAnimalModelQualificationProgram@fda.hhs.gov.

Please note that the email address used to register will be associated with the DDT and must be used for all subsequent submissions on that DDT (transfer of ownership can be requested by contacting FDA).

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