News
06/15/2009
In a joint statement issued today, MAPI Group (MAPI) of France announced its acquisition of controlling interest in the United States-based REGISTRAT, Inc. (REGISTRAT). REGISTRAT-MAPI will offer global Late Phase research services to the biopharmaceutical and medical device industry as the industy's largest clinical research organization (CRO) dedicated solely to real-world clinical research.
Read More
05/06/2008
The FDA says it will significantly expand its postmarketing safety activities, adopting new scientific approaches to drug safety to meet its commitments under the Prescription Drug User Fee Act (PDUFA IV).
Read More
04/07/2008
The FDA’s drug centers intend to spend their user fees to hire more safety evaluators, epidemiologists, regulatory project managers and experts in risk management and medication errors to enhance their postmarket drug-safety activities.
Read More