Analysis Life Sciences Thank You FDA’s new guidance on postapproval manufacturing changes for biosimilars focuses on current practice, new dosage forms
Agency IQ
JULY 26, 2024
in equipment) for products that are more complex or aren’t as well-characterized, such as antibody drug conjugates or recombinant DNA products, will be considered higher risk than they would if the change was made to the production of standard, small molecule products. Any CMC changes (e.g., Comments are due September 23, 2024.
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