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The FDA has appointed Paul Seligman Associate Center Director for Safety Policy and Communication in the Center for Drug Evaluation and Research (CDER).
The current adverse event reporting system is too passive to ensure drug safety, researchers say. Instead, a more active system involving insurance data mining, further analysis of electronic medical records and population-based databases is necessary to have a thorough post-approval monitoring system.
The FDA has issued a public health alert and Republican lawmakers are renewing calls for a ban on the medical abortion drug Mifeprex following reports that two more women had died after using the product.
Methods for collecting adverse-event data differ among trials, making it difficult for clinicians to compare risk-benefit profiles, claims a research team from the San Francisco Veterans Administration Medical Center.
Guidant is voluntarily advising physicians about lower battery voltage regarding two cardiac defibrillators, after receiving 39 reports of Contak Renewal 3 RF and Renewal 4 RF devices that exhibited the lower voltage.
The maker of Visicol, a drug used to prepare people for colonoscopies, says that Public Citizen’s recent report about a study linking some precolonoscopy drugs to kidney failure does not put the study results in proper context.
The New England Journal of Medicine issued a rare editorial that reiterates its December 2005 statement detailing concerns about a Merck study of Vioxx — only the third such editorial issued by the journal since 1991, an NEJM spokeswoman told CTA.