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.

FDA Guidance for Industry: Reformulating Drug Products That Contain Carbomers Manufactured With Benzene

Origin/Publisher:

FDA

Content:
The purpose of this guidance is to provide recommendations for applicants and manufacturers on what tests should be performed and what documentation should be submitted or available to FDA to support the reformulation of drug products that use carbomers manufactured with benzene

Go back

GMP Conferences by Topics