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