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congress
Latest Headlines
Latest Headlines
Senate vote looms on user fee legislation
The Senate could begin voting today on vital user fee legislation for both the medical device and drug industries, Bloomberg reports.
Hope runs high that FDA user fee bill will escape congressional acrimony
Our perpetually divided Congress hasn't yet passed a bill that would cover medical device and drug user fee agreements once the existing 5-year law expires in September. But there are some encouraging signs that legislators are trying to avoid roadblocks for the measure designed to fund a big chunk of both industries' regulatory reviews.
FDA closer to unveiling bar code system as Senate panel blesses UFA
Device safety has been a hot topic lately, with industry and patient safety groups weighing in. Now, the agency is fighting back as it works on a system for detecting malfunctions using medical and billing records from hospitals and insurance companies.
Device reviewers sue FDA over personal email monitoring
Six scientists and doctors who handled evaluations for FDA medical device approvals are suing their former employer. They accuse the regulatory agency of spying on their personal Gmail accounts for
EU breast implant scandal may affect FDA's view on faster device approvals
As the EU reels from the recent breast implant scandal , some experts now think the scandal could have an impact on the debate over faster device approvals in the U.S. In the U.S., industry and
Lawmakers seek recall info from Medtronic, 4 others
Three U.S. senators have fired off investigative letters to 5 devicemakers seeking information on how the companies conduct post-market surveillance, as well as on how they manage recalls when a...
Senators ask for IG investigation into PODs
Five U.S. senators have asked the HHS Inspector General to open an investigation into physician-owned distributorships--middleman entities that allow surgeons to profit from the medical devices they
Shuren to appear before House panel this week
CDRH head Jeffrey Shuren will finally appear before the a U.S. House Oversight & Government Reform subcommittee to discuss the FDA and its medical device approval process. The panel had been
Shuren to appear on Capitol Hill to discuss FDA approvals
CDRH head Jeffrey Shuren warned Tuesday the U.S. faces a "perfect storm" of challenges that threaten its global leadership position in medical technology. A weak economy, changing science and red
Senate votes down measure to kill medical device tax
The Senate voted 56-42 to kill an amendment sponsored by Sen. Pat Roberts (R-KS) that would have removed the medical device excise tax provision from the new healthcare reform law. Two members
