You only need the 2252. FDA confirmed this recently....Also, at my company we only do the 2252 and no questions from FDA.
"CDER's Johnathan Resnick confirmed that for annual reports to an approved ANDA, BLA, or NDA, only a Form FDA 2252 is required. A Form FDA 356h is not required to be submitted with these submissions."
DIA's RSIDM Ask The Regulators Session: What We Learned
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| DIA's RSIDM Ask The Regulators Session: What We Learned |
| DIA's Annual Regulatory Submissions, Information, and Document Management (RSIDM) Meeting is an excellent opportunity to learn the latest eCTD information and best practices. One of the most valuable sessions of the meeting is always the "Ask the Regulators" session, in which representatives from FDA answer questions directly from the attendees. |
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Cynthia Katsempris
Director, Regulatory Affairs
Lebanon, NJ
United States
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Original Message:
Sent: 08-Nov-2018 11:50
From: Vini Modi
Subject: Form 356H
Is 356H form required for ANDA annul report submission? Or just form 2252?
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Vini Modi, MSRA
NJ
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