FDA Clarifies Scope of Major Deficiencies in ANDA Refuse .pdf
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FDA Clarifies Scope of Major Deficiencies in ANDA Refuse-to-Receive Guidance
The FDA has again updated guidance on its criteria for refusing to receive an ANDA, providing a broader
definition for major deficiencies and downgrading four major deficiencies to minor ones in order to
make requirements less burdensome for industry.
In a second revision to the final guidance since last year, the FDA says a major deficiency is one that, in
its judgment, is significant in nature, whereas before the agency defined a major deficiency as one that
cannot easily be remedied.
The document reclassified four major deficiencies as minor, including the failure to:
Contain an environmental assessment or claim of categorical exclusion;
Provide English translations of each part of the application that is not in English;
Provide daily elemental iron calculation for products that contain iron; and
Provide the Pharmacy Bulk Package Sterility Assurance Table.
The changes are intended to clarify the scope of what FDA considers a major deficiency and better align
with its current practice. The guidance also relaxes the standards for refuse-to-receive notifications to
give industry some flexibility, the FDA said.
The remainder of the guidance mostly reiterates the major deficiencies laid out in the previous version.
Minor specifications have been added. For example, the FDA notes that it can refuse to receive an ANDA
when an FDA Form 356H is not signed, because this indicates that the sponsor is not attesting to the
material in the application.
The agency makes a point to remind sponsors that after May 5, 2017, ANDAs must be submitted in the
eCTD format. It also clarifies that batch studies should reference three time points — 0, 3 and 6 months,
and batch records should always be submitted, even when commercial scale-up is proposed.