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Pharmaceuticals / Regulatory Affairs

FDA Clarifies Scope of Major Deficiencies in ANDA Refuse-to-Receive Guidance

Dec. 30, 2016

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.

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