FDA Releases Guidance On CMC Changes To An Approved Application Certain Biological Products
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...
Source: meddeviceonline.com