The FDA has updated its regulatory business processes for supplements seeking only to withdraw a facility from New Drug Applications and Abbreviated New Drug Applications. Effective immediately, these supplements will receive an "acknowledge and retain" letter instead of an action letter.
For submissions proposing multiple changes, including a facility withdrawal, FDA will acknowledge the facility withdrawal in the initial acknowledgement communication. The acknowledgment will state that the 21 CFR 314.70 minor reportable change will be documented as withdrawn and maintained in the agency's administrative records, and that no further regulatory action with respect to the change will be taken for the supplement. The facility withdrawal will not be referenced in any subsequent action letter for that supplement.
Future facility withdrawal notifications may continue to be submitted through an appropriate post-approval changes notification pathway under 21 CFR 314.70.
For ANDA applicants only, FDA advised that to avoid the assessment of certain facility fees, facility withdrawal notifications should be submitted before the fiscal year due date for facility fees.
FDA said no action is required from applicants at this time. Questions should be directed to the appropriate Regulatory Business Project Manager in the Office of Pharmaceutical Quality, Office of Program and Regulatory Operations.
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