Study calls for more efficient, transparent FDA rule-making process
FDA rulemaking process lacks transparency, efficiency
US FDA Considering New Requirements for Off-Label Use Data
FDA has published updated draft guidance addressing distribution of scientific and marketing materials related to unapproved uses of medical devices, drugs and other products under Food and Drug Administration oversight. The agency was accepting public comments on the guidance through April 2014.
Medical Technology Assessment Board to be set up to assess medical technologies
The Department of Health Research (DHR) will set up a Medical Technology Assessment Board (MTAB) to evaluate all kinds of existing and new medical technologies, in line with the recommendation of the Planning Commission working group for the current Five Year Plan.
Congress restores $85M to FDA program for reviewing new drugs and medical devices
Congress has agreed to spare from sequestration about $85 million in user fees paid by life science companies to the Food and Drug Administration (FDA), according to U.S. Rep. Leonard Lance.
U.S. FDA provides 510(k) communication timeline
The US Food and Drug Administration recently added a new timeline to its 510(k) premarket notification webpage that summarizes typical communications between agency reviewers and medical device applicants between submission and final clearance.
14M networked medical devices to ship by 2018
Parks Associates predicts unit sales of networked medical devices will exceed 14 million units by 2018, more than five times the sales from 2012, according to a new report. The firm also looked at what connected medical devices consumers had in their homes.
GS1 Named First FDA-Accredited UDI Issuing Agency
Lawrenceville, N.J.-based GS1 US was named the first accrediting issuing agency for unique device identifiers (UDIs) by the U.S. Food and Drug Administration, according to a news release.
Report: 3D printing in medical device space is poised for growth; 3-D Printing for Medical Devices to Grow 15.4% Over 6 Years to $965M
The 3-D printing market for medical device applications is anticipated to grow 15.4 percent from 2013 to 2019, according to a Transparency Market Research report. In 2012, the market was valued at $354.4 million and is expected to reach $965.5 million in six years.
Device-tax-repeal language included in new budget proposal; U.S. medical device tax back on the chopping block
The latest iteration of the Bipartisan Budget Act of 2013 includes language that would strike down the 2.3% medical-device tax. The measure, which cleared the House last week, has been approved in the Senate and heads to President Barak Obama for his signature.
Will FDA Widen Use For The Vasecpa Fish Oil Pill, After All?
In a surprising development that has revived intense speculation over the fate of Amarin, the FDA has delayed any decision about whether to widen an indication for the Vascepa prescription fish oil pill. The move was expected in December 2013 and the delay has now triggered intrigue over what appears to be a complex minuet between the agency and the ‘little drugmaker that could.’