Later this month, generic drug manufacturers and related industry (or their authorized representatives) will be able to submit their controlled correspondence via the CDER Direct NextGen Collaboration Portal.
In just a few steps, you will be able to initiate and submit your controlled correspondence inquiry by filling out pertinent information and uploading the content requested. The Portal will enable you to receive, review, and respond to FDA communications in real time. It will also allow you to view the history of your communications with FDA in one convenient centralized location.
Your participation in submitting controlled correspondence via the CDER Direct NextGen Collaboration Portal will help FDA maximize efficiency during the generic drug review process.
While you will still be able to email controlled correspondence inquiries to CDER’s Office of Generic Drugs (OGD), the Portal benefits you by ensuring FDA has all the information needed to review your request and allowing you to view your history in one place. Additionally, at some point OGD will migrate to full utilization of the CDER Direct NextGen Collaboration Portal.
To register for an account with the CDER Direct NextGen Collaboration Portal, navigate to https://edm.fda.gov. Under the ‘Login’ section on the right of the screen, click on ‘New User’. On the ‘Request a Login’ page, check the ‘Controlled Correspondence’ event and provide all pertinent information such as contact information, organization information, and security questions. After submitting, your request will be validated, and you will receive an email with a confirmation/activation link.
Please email the Office of Generic Drugs (GenericDrugs@FDA.HHS.GOV) if you have questions about submitting controlled correspondence through the Portal.
Please see FDA’s draft guidance for industry, Controlled Correspondence Related to Generic Drug Development for additional information on FDA’s consideration of controlled correspondence.
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