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Did you know there are exemptions/waivers for FDA’s eCTD requirements for CDER applications?

In February 2020, the FDA released a Guidance Document regarding eCTD requirements for regulatory submissions. This guidance document describes how content must be organized in order to be submitted to the agency electronically for all submission types under section 745A(a) of the FD&C Act. However, there are exemptions.

For example, all Type III DMFs have been exempted from the eCTD format requirement as well as all submissions to noncommercial INDs. Although exempt from eCTD format, an alternative electronic format has been suggested for these submissions. There are several other conditions under which an applicant may request an eCTD exemption waiver. Certain Positron Emission Tomography Drug Submissions as well as DMFs intended to support an application for a PET drug are eligible for a long term waiver, provided the DMF contains information regarding radiolabeled drug products or production of PET radionuclides where the DMF holder is an academic institution, government entity or non-profit research organization.

Another exemption, eligible for a long-term waiver, applies to Type II DMFs solely used to support a noncommercial IND application, where the holder is an academic institution, government entity or a non-profit research organization. Additionally, short term waivers are available for application holders that are requesting withdrawal of an application that has not yet been converted to eCTD format. There are several other extraordinary circumstances that warrant a short-term waiver. Please see the guidance document for detailed information and instructions on how to apply for a waiver.

As always, EAS is available to assist in navigating this situation, including helping your firm understand which waivers or exemptions may apply in your situation. Contact Victoria Pankovich, Regulatory Specialist, for more information on eCTD submission requirements and EAS services in this area.

Posted in Did You Know, Drugs.