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FDA Releases Guidance On CMC Changes To An Approved Application: Certain Biological Products By Mark Durivage, Quality Systems Compliance LLC On June 21, 2021, the FDA released a new guidance, Chemistry, Manufacturing, and Controls Changes (CMCs) to an Approved Application: Certain Biological Products, to assist applicants and manufacturers of certain licensed biological products in determining which reporting category is appropriate for a change in chemistry, manufacturing, and controls (CMC) information to an approved biologics license application (BLA) as specified in 21 CFR 601.12 Changes to an approved application. This guidance finalizes the draft guidance, Chemistry, Manufacturing, and Controls Changes to an Approved Application: Certain Biological Products, dated December 2017, and supersedes the guidance titled Guidance for Industry: Changes to an Approved Application: Biological Products, dated July 1997. The guidance describes general and administrative information on ev

Mark durivagePublic health service actQuality systems complianceControls changesApproved applicationCertain biological productsBiological productsFederal foodCosmetic actBeing effectedChanges being effectedபொது ஆரோக்கியம் சேவை நாடகம்தரம் அமைப்புகள் இணக்கம்அங்கீகரிக்கப்பட்டது விண்ணப்பம்உயிரியல் ப்ராடக்ட்ஸ்கூட்டாட்சியின் உணவு