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The FDA and the Drug Enforcement Administration (DEA) are developing new, more explicit labeling guidelines for manufacturers of controlled substances like Purdue Pharma’s OxyContin and Abbott Laboratories’ Vicodin in an effort to curb widespread abuse of the prescription painkillers.
A bipartisan group of senators is threatening to block the confirmation of FDA Commissioner Mark McClellan as head of the Centers for Medicare & Medicaid Services (CMS) unless he answers questions about the FDA’s opposition to the reimportation of drugs.
HHS is going to form a congressionally mandated Drug Importation Task Force to study issues relating to the reimportation of drugs and release a report by December, the department said this week.
A pending court case raises the possibility that clinical trial participants have a continuing ownership interest in tissue samples and personally identifiable medical data, creating a potential obstacle for drugmakers trying to develop marketable products using those samples and data.
Medicaid administrators in Texas have not been verifying that drugmakers are paying the appropriate amount of interest on their overdue drug rebates, according to a report from the HHS Office of Inspector General (OIG).
President Bush has picked FDA Commissioner Mark McClellan to take over from Tom Scully as head of the Centers for Medicare & Medicaid Services (CMS) at HHS, according to the White House.
A congressional investigation into consulting arrangements and other undisclosed financial relationships between drugmakers and staff at the National Institutes of Health (NIH) has resulted in a demand for more information about a loophole that has allowed institute directors and other top officials to escape disclosure requirements.
The HHS Office of Inspector General (OIG) has recommended that the Centers for Medicare & Medicaid Services (CMS) make sure that all the paperwork is done to resolve problems the OIG found in auditing several state programs to collect rebates from drugmakers on drugs purchased by Medicaid.
Two pending Medicare coverage decisions and an underlying policy stance taken by the Centers for Medicare & Medicaid Services (CMS) are creating a risk that drugmakers may not be able to sell their products to senior citizens, even after obtaining FDA marketing approval, according to the Washington Legal Foundation (WLF).
New Hampshire has joined the list of states where officials need to keep better track of whether drugmakers pay the rebates they owe on drugs covered by Medicaid, according to the HHS Office of Inspector General (OIG).