Biologics Approved In 2012
This article was originally published in Pharmaceutical Approvals Monthly
FDA transferred review of most therapeutic biologics to the Center for Drug Evaluation & Research on Oct. 1, 2003. The Center for Biologics Evaluation & Research continues to review other biologics, including vaccines, cellular products, antitoxins and immunoglobulins.
You may also be interested in...
Agency must plan to ensure that a growing backlog of surveillance inspections does not impede its ability to conduct inspections at high-risk sites, GAO official says.
Trademarks are registered and published for opposition with the US Patent and Trademark Office and are published weekly in the agency's Official Gazette.
Judge ordering permanent injunction against Confidence USA on a complaint filed in 2019 questioned FDA's calculations for requiring the firm to recall and destroy all products it had distributed since February 2018.