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The following guideline can be ordered through the address listed in the "Source/Publisher"-category.
In cases in which you can order through the Internet we have established a hyperlink.
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| Comparability Protocols - Protein Drug Products and Biological Products . Chemistry, Manufacturing, and Controls Information |
| Internet: | http://www.fda.gov/cder/guidance/protcmc.pdf |
| Origin/Publisher: | FDA |
| Content: | This guidance provides recommendations to you, the applicant, on preparing and using comparability protocols for changes in chemistry, manufacturing, and controls (CMC) of products2 in approved marketing applications. |
| Status: | Draft |
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