FDA Guidance Update – Postapproval Chemistry, Manufacturing and Controls Changes

FDA Draft Guidance BiologicsOn April 19th, 2016, the Regulatory Affairs Professionals Society (RAPS) shared that the FDA Draft Guidance for “Comparability Protocols governing Human Drugs and Biologics: Chemistry, Manufacturing, and Controls Information” had been changed.  Drug and biologics manufacturers looking to implement a chemistry, manufacturing and controls (CMC) postapproval change may find this of value.  You can view the full RAPS announcement on the RAPS website using the following link:  http://raps.org/Regulatory-Focus/News/2016/04/19/24790/Postapproval-CMC-Changes-FDA-Updates-Guidance/?utm_source=Email&utm_medium=Informz&utm_campaign=RF-Today

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