Regulatory Open Forum

I am interested in learning more about common practice of the process based on your experience. My understanding is that FDA does not approve submissions like CBE-0 or CBE-30, but will they will inform the sponsor if the submission pathway is not appropriate and a PAS is required instead. Based on your experience, does FDA react in 30 days or may they come back for a period of 6 months to provide the feedback that the submission is not appropriate?  I understand a comprehensive review of a CBE will presumably take more time than 30 days, so FDA may come back for a period of Time (6 months?) to reject the change?

It is not true that FDA does not approve CBE-0 or CBE-30 supplements. In fact, the FDA does issue Approval Letters in 4-6 months after submission of the supplement. The Sponsor should have a fairly good idea that a CBE-0 or CBE-30 submission category is appropriate and that it will be accepted by FDA. It would be prudent to make a conservative regulatory assessment when deciding on the submission category. Per the regs, Quality is able to release product to market when the CBE-0 is filed or 30 days after a CBE-30 is filed. This release is done 'at-risk'. If FDA later rejects your submission category or the submission altogether, it may trigger market action (i.e., recall).

I am interested in learning more about common practice of the process based on your experience. My understanding is that FDA does not approve submissions like CBE-0 or CBE-30, but will they will inform the sponsor if the submission pathway is not appropriate and a PAS is required instead. Based on your experience, does FDA react in 30 days or may they come back for a period of 6 months to provide the feedback that the submission is not appropriate?  I understand a comprehensive review of a CBE will presumably take more time than 30 days, so FDA may come back for a period of Time (6 months?) to reject the change?

It is not true that FDA does not approve CBE-0 or CBE-30 supplements. In fact, the FDA does issue Approval Letters in 4-6 months after submission of the supplement. The Sponsor should have a fairly good idea that a CBE-0 or CBE-30 submission category is appropriate and that it will be accepted by FDA. It would be prudent to make a conservative regulatory assessment when deciding on the submission category. Per the regs, Quality is able to release product to market when the CBE-0 is filed or 30 days after a CBE-30 is filed. This release is done 'at-risk'. If FDA later rejects your submission category or the submission altogether, it may trigger market action (i.e., recall).

Annette, you asked me for regulation or guideline where it states that FDA will issue Approval Letters in 4-6 months after submission of a CBE-0 or CBE-30 supplement.  You will find it in the PDUFA Guidelines: FDA will review and act on 90% of supplements within 6 months. "Act" is hopefully the issuance of an Action Letter (i.e., approval letter and not a Complete Response Letter where FDA has queries).

If you read the PDUFA guidelines, you will be interested to see that in comparison 90% of prior-approval supplements will be reviewed/acted on within just 4 months!