Drugs

CMC Postapproval Manufacturing Guidance

FDA has published a guidance, CMC Postapproval Manufacturing Changes for Specified Biological Products To Be Documented in Annual Reports, with recommendations to holders of BLAs for specified biological products regarding the types of changes to an approved BLA to be documented in an annual report. The document says it describes CMC postapproval manufacturing changes that FDA generally considers to have a minimal potential to have an adverse effect on product quality.

“Under FDA regulations,” the guidance says, “postapproval changes in the product, production process, quality controls, equipment, facilities, or responsible personnel that have a minimal potential to have an adverse effect on product quality must be documented by applicants in an annual report.”

The guidance applies to biological products that are either therapeutic DNA plasmid products, therapeutic synthetic peptide products of 40 or fewer amino acids, monoclonal antibody products for in vivo use, or therapeutic recombinant DNA-derived products. It also applies to combination products licensed under a BLA where the biological product constituent part falls under one of the four categories.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome