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XI. DEFINITIONS
A. Act on – with respect to an application, means FDA will either issue a CRL, an approval,
a tentative approval, or a refuse-to-receive action.
B. Ambiguity in the Controlled Correspondence response – means the Controlled
Correspondence response or a critical portion of it merits further clarification.
C. Review Status Update – means a response from the RPM to the applicant to update the
applicant concerning, at a minimum, the categorical status of relevant assessment
disciplines with respect to the submission at that time. The RPM will advise the applicant
that the update is preliminary only, based on the RPM’s interpretation of the submission,
and subject to change at any time.
D. Capacity Planning Adjustment – Methodology that annually adjusts inflation-adjusted
target revenue to account for additional resource needs due to sustained increases in
workload for the GDUFA program.
E. Complete Response Letter– refers to a written communication to an applicant or DMF
holder from FDA usually describing all of the deficiencies that the Agency has identified
in an ANDA (including pending amendments) or a DMF that must be satisfactorily
addressed before the ANDA can be approved. Complete response letters will reflect a
Complete Assessment, which includes an application-related facilities assessment and
will require a complete response from industry to restart the clock. Refer to 21 CFR
314.110 for additional details. When a citizen petition may impact the approvability of
the ANDA, FDA will strive to address, where possible, valid issues raised in a relevant
citizen petition in the complete response letter. If a citizen petition raises an issue that
would delay only part of a complete response, a response that addresses all other issues
will be considered a complete response.
F. Complete Assessment – refers to a full division-level assessment from all relevant
assessment disciplines, including inspections, and includes other matters relating to the
ANDAs and associated DMFs as well as consults with other Agency components.
G. Complex Product – generally includes:
1. Products with complex active ingredients (e.g., peptides, polymeric compounds,
complex mixtures of APIs, naturally sourced ingredients); complex formulations
(e.g., liposomes, colloids); complex routes of delivery (e.g., locally acting drugs such
as dermatological products, complex ophthalmological products, and otic dosage
forms that are formulated as suspensions, emulsions or gels) or complex dosage
forms (e.g., transdermal systems, metered dose inhalers, extended release injectables)