Issue Date: 24Jun2022
The US Food and Drug Administration has recently issued a final guidance for sponsors and applicants who receive an exemption or a waiver from providing regulatory submissions in electronic common technical document (eCTD) format.
In section 745A(a) of the FD&C Act, Congress granted FDA the authority to implement the Agency’s statutory electronic submission requirements in guidance. In response to this authorization, FDA implemented binding guidance requiring submission of new drug applications (NDAs), abbreviated new drug applications (ANDAs), certain drug master files (DMFs), certain biologics license applications (BLAs), and certain investigational new drug applications (INDs) to the Agency in eCTD format. Recognizing that certain types of submissions are exempt from this requirement and that waivers of the requirement may be granted on a case-by-case basis, the Agency is issuing this guidance to describe the alternate electronic format companies should use for submissions covered under such exemptions and waivers. Sponsors and applicants who receive an exemption or a waiver from filing in electronic common technical document (eCTD) format under section 745A(a) of the FD&C Act should still provide those exempted or waived submissions electronically. This recommendation is consistent with the efforts of Federal Agencies to transition their business processes and record-keeping to a fully electronic environment.
Click the link below to read and download the FDA Guidance Document on Providing Regulatory Submissions in Alternate Electronic Format
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