Drugs

PAS Classification Category Guidance

FDA has published a draft guidance, Classification Categories for Certain Supplements Under BsUFA 3, with recommendations on classification categories A, B, C, D, E, and F for original and resubmitted prior approval supplements submitted to approved section 351(k) applications. The document says the BsUFA 3 agreement sets forth the supplement classification categories and their associated review performance goals. “This guidance is intended to help applicants identify the appropriate classification category and review goal date of the supplement being submitted,” it says.

The categories pertain to supplements for biosimilar and interchangeable biosimilar products for applicants seeking to:

update prescribing information and, if applicable, FDA-approved patient labeling with safety information that has been updated in the reference product labeling and applies to one or more indications for which the biosimilar or interchangeable biosimilar product is licensed;
receive licensure for an additional indication;
remove an approved indication;
receive an initial determination of interchangeability.

Supplements to approved 351(k) BLAs that do not meet the criteria under categories A-F are outside the guidance scope and not addressed in it, FDA says.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

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FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome