Drug and biologics manufacturers looking to implement a chemistry, manufacturing and controls (CMC) postapproval change through the use of a comparability protocol (CP) should take note of an updated ...
The US Food and Drug Administration’s (FDA) last week released a final guidance to assist the pharmaceutical industry in submitting comparability protocols for postapproval manufacturing changes. The ...
The guidance discusses the implementation of CMC postapproval changes through a comparability protocol. On April 19, 2016, FDA issued guidance on how to implement a chemistry, manufacturing, and ...
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