FDA Draft Guidances: ANDA Submissions – Refuse to Receive for Lack of Proper Justification of Impurity Limits & Refuse-to-Receive Standards

14.11.06FDA has released two draft guidance documents on refuse to receive ANDA submissions. The purpose of the guidances are to help applicants prepare “ANDAs and PASs to ANDAs for which the applicant is seeking approval of new strengths of the drug product” by outlining when the agency may refuse to receive based on various deficiencies.

The first guidance focuses on refusing to receive for lack of proper justification of impurity limits. The guidance highlights deficiencies in relation to information about impurities that may cause FDA to refuse to receive an ANDA. “Typical deficiencies that lead to a refuse-to-receive decision include:

  1. Failing to provide adequate justification for proposed limits in drug substances and drug products for specified identified impurities that are above qualification thresholds;
  2. Failing to provide adequate justification for proposed limits for specified unidentified impurities that are above identification thresholds;
  3. Proposing limits for unspecified impurities (e.g., any unknown impurity) that are above identification thresholds.”

The second guidance focuses on deficiencies that may cause FDA to refuse-to-receive an ANDA. “If FDA determines that an ANDA contains ten or more minor deficiencies, or one or more major deficiencies, FDA will consider such an application not sufficiently complete to permit a substantive review.” In this case, FDA will notify the applicant that FDA does not consider the ANDA to have been “received.” If the applicant submits “additional materials to correct the deficiencies, the resulting amended ANDA will be considered a new ANDA submission, received as of the date the amendment to the ANDA is received and the applicant will be required to pay a new GDUFA fee.”

If “FDA determines that an ANDA has fewer than ten minor deficiencies…FDA will notify the applicant of the deficiencies.” If the applicant subsequently provides satisfactory amendments to the “ANDA to correct the identified deficiencies within 7 calendar days and FDA makes the determination to receive the application as amended, the application will be considered received as of the date on which it was first submitted to FDA.”

The two guidances can be reviewed here:

ANDA Submissions – Refuse to Receive for Lack of Proper Justification of Impurity Limits
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM414598.pdf

ANDA Submissions – Refuse-to-Receive Standards
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM370352.pdf

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