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Outgoing Senate Majority Leader Bill Frist's (R-Tenn.) last-minute effort to push through the Bush administration's choice to be the FDA commissioner was successful as the Senate voted overwhelmingly last week to approve the nomination.
Trionix Research Laboratory neglected to perform device change procedures on a faulty product and did not inform the FDA of the malfunction, a recent agency warning letter said.
The FDA granted conflict-of-interest waivers to five advisory committee members with ties to drug-eluting stent manufacturers or drugmakers who manufacture the coatings for the devices so they could participate in a recent meeting examining the safety of the devices.
There is currently no evidence of increased rates of death or heart attack from drug-eluting stents versus bare-metal stents, but more trials with consistent protocols are needed to adequately assess the risk, an FDA panel concluded Dec. 7.
Lawmakers should not interfere with the current off-label prescribing system because doing so would limit patients’ access to the most innovative treatments, a high-ranking FDA official says.
The FDA’s long-awaited revision of Part 11, which is now slated for release in the first part of 2007, will impose major new burdens on the pharma industry in the area of risk assessment and management, according to Martin Browning, president of EduQuest and a former FDA official.
The FDA is supporting a user fee program for direct-to-consumer (DTC) advertising, where companies are only required to pay when they have ads up for review, a high-ranking agency official told WDL.
Outgoing Senate Majority Leader Bill Frist’s (R-Tenn.) last-minute effort to push through the Bush administration’s choice to be FDA commissioner was successful as the Senate voted overwhelmingly late Dec. 7 to approve the nomination.
Outgoing Senate Majority Leader Bill Frist’s (R-Tenn.) last-minute effort to push through the Bush administration’s choice to be the FDA commissioner was successful as the Senate voted overwhelmingly last night to approve the nomination.