Food and Drug Administration Analysis of Ticagrelor

Overview of the 2010 Food and Drug Administration Cardiovascular and Renal Drugs Advisory Committee meeting regarding ticagrelor.

Landmark clinical trials established the benefit of the thienopyridine clopidogrel, an irreversibly binding inhibitor of the platelet P2Y12 receptor, in the setting of acute coronary syndromes (ACS).1–3 Clopidogrel has thus become a key component of the current standard of care for antiplatelet therapy in the setting of ACS.4,5 Evidence has emerged, however, regarding the inherent limitations o...

Special Report Overview of the 2010 Food and Drug Administration Cardiovascular and Renal Drugs Advisory Committee Meeting Regarding Ticagrelor

Landmark clinical trials established the benefit of the thienopyridine clopidogrel, an irreversibly binding inhibitor of the platelet P2Y12 receptor, in the setting of acute coronary syndromes (ACS).1–3 Clopidogrel has thus become a key component of the current standard of care for antiplatelet therapy in the setting of ACS.4,5 Evidence has emerged, however, regarding the inherent limitations o...

Food and Drug Administration regulation of food safety.

New food safety initiatives in the Food and Drug Administration.

Concern over the presence of veterinary drug residues in food has been increasing world wide. Because of this concern the Food and Drug Administration's Center for Veterinary Medicine (CVM) has been involved on an international basis in efforts to develop food safety standards for veterinary drugs. The major thrust of the Codex Committee on Residues of Veterinary Drugs in Foods (CC/RVDF) has be...

Food and Drug Administration regulation and evaluation of vaccines.

The vaccine-approval process in the United States is regulated by the Center for Biologics Evaluation and Research of the US Food and Drug Administration. Throughout the life cycle of development, from preclinical studies to after licensure, vaccines are subject to rigorous testing and oversight. Manufacturers must adhere to good manufacturing practices and control procedures to ensure the qual...