Can I read FDA Guidance on Comparability Protocols on EtoBox?

FDA Guidance on Comparability Protocols by bheemanna munnur is a document available to read on EtoBox.

What is FDA Guidance on Comparability Protocols about?

The FDA is holding a meeting of the Manufacturing Subcommittee of the Advisory Committee for Pharmaceutical Science on September 17, 2003, to discuss quality by design and risk management principles. The agency has also announced the availability of a draft guidance document on comparability protocols for protein drug products and biological products. Comments on the draft guidance are invited until December 4, 2003, and the document will inform applicants on preparing and using comparability protocols in v

Author

bheemanna munnur

Language

EN