Regulatory News

  • FDA policy would accelerate approval of drug cocktails

    The FDA is formulating guidelines that would speed up testing and approval of multidrug cocktails for potentially life-threatening diseases that lack treatments. The policy is expected to benefit the Critical Path to TB Regimens, a collaboration of major drugmakers and nonprofit groups assembled by the Bill & Melinda Gates Foundation.

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  • Ban on pay-for-delay deals might get dropped from health bill

    A complex process that Congress will use to vote on the health reform bill might lead to the exclusion of a proposal to ban pay-for-delay deals between brand-name and generic-drug firms. Sen. Herb Kohl, D-Wis., intends to push the provision later if it gets dropped from the overhaul legislation, a spokeswoman said.

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  • Drugmakers face scrutiny regarding domestic versus foreign prices

    Senate Special Committee on Aging Chairman Herb Kohl, D-Wis., asked six major drugmakers to explain the "large discrepancies" in prescription prices between the U.S. and other developed countries. A spokesman for Eli Lilly and Co. attributed the difference in part to government price controls in other markets and greater accessibility of medicines in the U.S.

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  • FDA Transparency Task Force seeks public comment

    The FDA created the Transparency Task Force to be more open about its oversight of drugs. The task force will recommend what information the agency should share publicly and is seeking comments from consumers, the FDA said.

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  • Dynavax aims to submit application for hepatitis B vaccine early

    Dynavax Technologies completed enrollment for a Phase III trial of hepatitis B vaccine Heplisav and expects to have participants immunized soon. The development will allow the company to submit a biologics-license application to the FDA in the third quarter of 2011, six months earlier than estimated, Dynavax said.

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  • FDA orders Glenmark, Konec to stop selling nitroglycerin tablets

    The FDA warned Glenmark Generics and Konec to halt production and marketing of unapproved nitroglycerin tablets used to treat chest pain in patients with heart problems. The move is part of the agency's Unapproved Drug Initiative, which aims to prevent illegal circulation of prescription medications.

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