AdvaMed carefully commends president’s corporate tax reform framework
Tracking tax reform continues to be a high priority for AdvaMed as evidenced by its response to President Obama’s framework for business tax reform. The framework proposes lowering corporate tax rates and paying for that by closing various corporate tax loopholes. ...
Health subcommittee holds hearing for MDUFA reauthorization
The Subcommittee on Health held a hearing on Feb. 15, 2012, entitled, “Reauthorization of the Medical Device User Fee Act (MDUFA): What It Means for Jobs, Innovation, and Patients.” During the two-hour hearing, members of Congress and the medical technology industry discussed issues involved with the new user fee agreement and the ongoing negotiation between FDA and industry....
Sunshine Act: AdvaMed comments aimed at clarifying context, ensuring accuracy of posted data
AdvaMed, which has long supported appropriate disclosure of relationships between medical technology companies and physicians, submitted comments to CMS last week in response to the CMS rulemaking outlining its proposed rule to “increase public awareness of financial relationships between drug and device manufacturers and certain health care providers.” The rule was issued at the end of 2011 for comment....
IRS issues medical device tax regs; AdvaMed urges repeal
Today’s release of proposed regulations to implement the $20 million medical device tax scheduled to go into effect next year drew this response from AdvaMed President and CEO Stephen Ubl...
AdvaMed praises de novo legislation
The “Improving Safety, Efficiency & Transparency in Device Regulation Act.” sponsored by Sen. Bob Casey, Jr. (D-PA) and Sen. John McCain (R-AZ), has the full support of AdvaMed, as evidenced by this statement released today by AdvaMed President and CEO Stephen Ubl...
Latest device user-fee agreement could be game-changer, but first . . .
This week’s announced tentative agreement on a new “Medical Device User Fee Act” by FDA, AdvaMed, and other trade associations, including MDMA and MITA, deserves praise and requires scrutiny....
FDA and CMS: A path for parallel approvals for innovative technologies
Parallel FDA and CMS review offers an opportunity to reduce the time it now takes to secure Medicare coverage and payment for innovative new products....
Legislation prompts positive responses from AdvaMed
New legislation introduced to improve the de novo classification process for medical technology received kudos from AdvaMed as did the “Medical Device Patient Safety Act”. ...
FDA-ABIA partnership targets safer, better-performing materials
FDA and Austen BioInnovation Institute in Akron (ABIA) have entered into a groundbreaking collaboration to support and develop regulatory science for the safe and effective use of biomaterials in medical devices. ...
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