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The FDA needs to offer more detail on how the proprietary interests of drugmakers would be protected in its draft guidance on pharmacogenomics that calls for voluntary genomic data submissions (VGDSs), Eli Lilly told the agency in recent comments.
The FDA’s guidance on risk management plans (RMPs) for controlled substances that could be categorized by the Drug Enforcement Administration (DEA) as schedule II drugs should encourage manufacturers submitting new drug applications to include plans for monitoring their use and identifying potential abuse and diversion problems, according to the General Accounting Office (GAO).
The FDA is continuing its battle to stop the illegal importation of prescription drugs from Canada, issuing a warning letter Jan. 22 to a pharmacy benefits manager (PBM), insurance company and claims processor. PBM Expedite-Rx, claims processor SPC Global Technologies and insurer Employer Health Options were accused by the agency of “facilitating illegal imports of [Rx] drugs from Canada and misleading the public about the drugs’ safety.”
FDA Commissioner Mark McClellan could be in the running to lead the Centers for Medicare & Medicaid Services (CMS) — a critical position in the Bush administration’s efforts to institute far-reaching changes in the Medicare program, which includes prescription drug benefits approved by Congress last year.
The FDA last week ramped up its efforts to convince U.S. cities that importing drugs from Canada is a bad idea, releasing details of a second import blitz showing that the only thing Canadian about many of the drugs seized was the postmark on the packages in which they were to be delivered.
The FDA has been asked by a high-ranking House Democrat to explain why the enforcement of regulations barring false and misleading drug advertisements has declined, despite promises from agency Commissioner Mark McClellan that actions would increase.
The manufacturers of antidepressants like Prozac, Zoloft and Paxil are coming under fire from U.S. researchers for refusing to release negative clinical trial data, thus denying access to critical information needed to assess the safety of the drugs for use in children.
Acting industry representatives serving on the Center for Drug Evaluation and Research's (CDER's) advisory committees may become permanent in the next three to six months when the center plans to make those positions permanent but still nonvoting, Igor Cerny, acting director of the CDER's advisory committee group, told DID.
An activist group is urging HHS Secretary Tommy Thompson to use the 1980 Bayh-Dole Act to grant generic firms patent licenses to manufacture versions of Pfizer’s glaucoma drug Xalatan (latanoprost) and Abbott’s AIDS treatment Norvir (ritonavir).