Center for Drug Evaluation and Research (CDER)

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Serious Risks and Few New Benefits from FDA-Approved Drugs

Donald W. Light | Health Affairs Blog | July 6, 2015

Over the past year, the U.S. Senate and The New York Times have been investigating the failure of the nation’s auto safety regulators to protect citizens from cars with occasionally dangerous faulty devices. But neither august institution has paid attention to the Food and Drug Administration’s (FDA) failure to protect the 170 million Americans who take prescription drugs from adverse reactions that are killing more than 2,400 people every week. Annually, prescription drugs cause over 81 million adverse reactions and result in 2.7 million hospitalizations...

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TransCelerate Identifies Pharmacovigilance as an Operational Challenge in Need of Transformation

Press Release | TransCelerate BioPharma Inc. | March 29, 2017

TransCelerate BioPharma Inc. today announced that it has added Pharmacovigilance to its portfolio, establishing two new global initiatives: 1.) Interpretation of Pharmacovigilance Regulations and 2.) Value of Safety Information Data Sources. Both initiatives aim to create solutions that will reduce resource inefficiencies, enhance information exchange with global health authorities and improve patient safety to drive more value for patients...