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As work on the new Medicare law descends into the trenches of implementation, the drug industry is rapidly hiring former federal government regulators and Capitol Hill staffers who know how to navigate the regulatory terrain on which success or failure will be decided.
The FDA’s acting commissioner said the agency has no choice but to remain open-minded about generic biologics after a U.S. senator urged the FDA to address the legal and regulatory foundations before releasing a scientific guidance for producing the complex products.
Concerned over the FDA’s growing momentum toward developing an approval process for generic biologics, a U.S. senator has urged the agency to address the legal and regulatory foundations before releasing a scientific guidance for producing the complex products.
A recent ruling from the U.S. Court of Appeals for the Federal Circuit shoots down the argument that the combination of previously existing drugs creates a new product eligible for a patent term extension.
Bowing to pressure from the ranking Democrat on the House Ways and Means Committee, Rep. Bill Thomas (R-Calif.), chairman of the committee, has scheduled a second hearing to investigate allegations the Bush administration intimidated the chief actuary at the Centers for Medicare & Medicaid Services (CMS) to prevent him from releasing cost estimates on the new Medicare law.
The chairman of the Senate Finance Committee has ramped up his investigation into allegations the FDA withheld -- and continues to withhold -- a report that says there may be increased risk of suicide among children taking antidepressant medications, and demanded the agency provide records and make officials available for interviews.
Lawmakers from the House Energy and Commerce Committee demanded last week the FDA release scores of agency records related to the potential suicide risk posed by antidepressant use among children and whether an agency medical officer was prevented from presenting findings at an advisory committee meeting last month.
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.
The FDA has told Carolina Pharmaceuticals to stop marketing two reformulated versions of the cold and flu drug Humibid (guaifenesin) extended-release tablets, according to a recent warning letter.
The Senate has approved FDA Commissioner Mark McClellan’s nomination to head the Centers for Medicare & Medicaid Services (CMS), even as key senators predict Congress will pass legislation this year allowing for the reimportation of pharmaceuticals and negotiated prices for drugs purchased under Medicare.