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A Canadian devicemaker could start having its U.S.-bound products seized at the border unless it corrects numerous good manufacturing practices (GMP) and documentation violations discovered at its production facility.
The FDA has accused a Middletown, Pa., devicemaker of using misleading statements in promotional materials and purporting unapproved devices as cleared.
Early sales figures for Boston Scientific’s drug-coated Taxus stent indicate the device is well on its way to meeting the company’s goal of capturing 70 percent of the U.S. coronary stent market within 70 days of launch.
Mark McClellan, outgoing FDA commissioner, was sworn in as the new administrator at the Centers for Medicare & Medicaid Services (CMS) yesterday afternoon and will begin work at CMS this morning, according to an HHS spokesperson.
A clinical investigator in Alabama has been sentenced to prison time and ordered to make financial restitution to a drugmaker after being convicted of mail fraud for reporting falsified data from a drug trial.
Generic firms Endo Pharmaceuticals and Teva Pharmaceutical have received final FDA approval to market versions of Purdue Pharma’s powerful pain treatment OxyContin (oxycodone HCl), but ongoing patent litigation has put a hold on the product launches.
Two House leaders yesterday demanded the FDA provide them with a massive number of agency records related to the potential for increased risk of suicide in children taking antidepressant drugs and to whether an FDA official was prevented from presenting his findings at an advisory committee meeting in February.