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Will FDA continue to accept applications in paper format?

1.06K viewsOctober 10, 2022DrugsPharmaceutical
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Sam Smith11.38K November 25, 2020 0 Comments

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Blogolu28.38K Posted November 25, 2020 0 Comments

Yes, for the time being. Applications received in paper format after October 1,
2012, however, will not be included as part of the new performance metrics
established in GDUFA. Additionally, electronic submissions will be required as of
May 5, 2017, which is 24 months after issuance of final Guidance for Industry,
Providing Regulatory Submissions in Electronic Format — Certain Human
Pharmaceutical Product Applications and Related Submissions Using the eCTD
Specifications.7 FDA will refuse-to-receive an ANDA that is not submitted in
electronic format as specified in the final guidance submitted on or after May 5,
2017.

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