IDC Health Insights assessed eight drug safety
service providers for this report, which is designed to evaluate the characteristics of each firm.
Pharmaceutical company Aerie Pharmaceuticals Inc (NasdaqGM:AERI) revealed on Monday the addition of Huan Sheng, MD, PhD as director of its clinical research and drug safety
Klepper released the following statement: "We are so pleased to add Lynda Spiker to the Drug Safety
Through the move, Telerx adds drug safety
outsourcing to its pharmaceutical and healthcare business unit, the buyer said.
Traditionally, drug safety
groups have operated as drug safety
factories, which incurred significant capital expenses in building infrastructure related to technology, processes, people and other operational investments.
PRA currently operates two dedicated drug safety
centers in Charlottesville, VA and Mannheim, Germany.
The new China-US agreement on drug safety
specifies new requirements for both countries for the registration and certification of drug ingredient manufacturers, as well as new procedures for information sharing, notification of adverse events, determination of counterfeits and facility access.
Groups such as Consumers Union criticized the plan, however, saying it fell short of the changes needed to overhaul the nation's drug safety
The information in the guidance, "Drug Safety
Information-FDA's Communication to the Public," is intended to make emerging information on important drug safety
issues available to the public and will facilitate patient and healthcare provider access to the most current information concerning the potential risks and benefits of a marketed drug.
Our proposed recommendations for PDUFA IV aim to top these accomplishments by achieving an impressive expansion and modernization of our drug safety
system and adding resources to enhance information technology initiatives.
Officials at the Food and Drug Administration are planning to reorganize its Center for Drug Evaluation and Research in an effort to improve the agency's approach to drug safety
and to help improve drug development.
The current organizational structure perpetuates the mis-perception that ensuring drug safety
is solely the responsibility of the current Office of Drug Safety
Many questions surround the authority of a new drug safety
board that would oversee the management of drug safety
and provide emerging information to physicians and patients about the benefits and risks of medicines on the market.
Graham of FDA's Office of Drug Safety
in Rockville, Md.
org/) formed a project committee to develop a collaborative scientific program to identify and address some of the key issues arising from the emerging application of toxicogenomics to drug safety