We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
GlaxoSmithKline (GSK) will implement a plan that will allow people enrolled in the Medicare Part D program to reapply to GSK’s patient assistance program for transitional assistance through the end of the year.
Congress must appropriate the FDA more money if it wants the agency to be able to meet the demand for improved post-market studies of drug safety and accelerated approval of new brand and generic drugs, a key agency official said.
Just days after missing a deadline set by Sen. Chuck Grassley (R-Iowa) for a briefing related to its controversial approval of the antibiotic Ketek, the FDA informed the Senate Finance Committee chairman last week that it would provide him with all the information he had requested on the review of the drug.
The FDA opposes lawmakers’ efforts to limit the agency’s
ability to grant conflict-of-interest waivers for advisory committee members, arguing that such a move would undermine its ability to have the necessary expert advice needed to make drug policy, an agency official says.
The FDA is launching an internal assessment to establish best practices in its advisory committee meeting system as part of a broader effort to modernize its approach to managing drug reviews, the agency said.
Bipartisan Senate trade legislation is unlikely to reduce the risk of intellectual property (IP) violations faced by the pharmaceutical sector when trading with China, experts say.
Congress should consider establishing a uniform payment schedule for 2008 for Class II and III devices, says a Government Accounting Office (GAO) report, released March 1.
Sen. Mike Enzi (R-Wyo.), chairman of the committee with jurisdiction over the FDA, will soon introduce his long-awaited drug safety legislation as his focus turns from public hearings on the issue to staff-level negotiations between his and the ranking member’s staff.