IPQ: BLA CMC Problem Areas Include Lack of Transparency in Supplement Cover Letters, FDA Reports

FDA is urging sponsors filing Biologic License Application (BLA) supplements to clearly highlight the significant changes and their scope in the cover letter to expedite the agency review and approval process.

The advice reflects the agency’s experience that supplement filers are not always giving it a clear picture up-front, resulting in significant review delays or a Complete Response (CR) letter indicating that the application is not approvable in its current form.

In turn, providing too much information on aspects of existing facilities that have not changed – for example, through hyperlinks to prior submissions – can also slow down the process as the reviewer must take time determining what has changed and what has not.

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