News
05/10/2012
The House Energy and Commerce Committee held a full committee markup this week of H.R. 5651, "The Food and Drug Administration Reform Act of 2012," which consists of all the user fee proposals....
05/07/2012
WASHINGTON, DC – MDMA today submitted comments to the Internal Revenue Service (IRS) regarding its proposed regulations for the 2.3% medical device tax that passed as a part of the Affordable Care...
04/24/2012
The Senate HELP Committee marked-up legislation incorporating the various user fees today, including MDUFA. The committee rejected certain amendments that were offered to alter the bill, which...
04/18/2012
The House Energy and Commerce Subcommittee on Health held a hearing today entitled "FDA User Fees 2012: How Innovation Helps Patients and Jobs," to examine all of the proposed user fee negotiations,...
04/10/2012
With gathering concerns and pressure from providers that there was not enough time for them to overhaul their billing systems, the Center for Medicare and Medicaid Services (CMS) this week delayed...
03/28/2012
The Senate Health, Education, Labor, and Pensions (HELP) Committee held a hearing this week to discuss the proposed agreement on user fees and other enhancements to FDA's regulatory processes...
03/27/2012
The FDA issued a new guidance document this week designed to clarify the principal factors CDRH will consider when making benefit-risk determinations in premarket approvals (PMAs) and de novo...
03/23/2012
Initial estimate of a $20 billion tax already ballooned to $30.5 billion
WASHINGTON, DC – While the 2.3% medical device tax isn’t scheduled for implementation until 2013, its impact is already being...
03/08/2012
The House of Representatives overwhelmingly passed the "Jumpstart Our Business Startups (JOBS)" Act this week, where it now heads to the Senate for consideration. This represents one of the...
03/01/2012
As MDMA and other stakeholders continue to finalize work on the MDUFA negotiations, Congressional Appropriation Committees have begun to hold hearings on FDA's funding.FDA Commissioner Margaret...
