The US Food and Drug Administration (FDA) has released two long-awaited guidance documents regarding the appeals process to be used by medical device manufacturers that have received a rejection by the agency.
The US Food and Drug Administration has published a report updating its plans for a nationwide medical device post-market surveillance system, including implementation of a Unique Device Identification (UDI) framework.
The refurbished medical equipment market is slated to be worth $9 billion by 2018, building at an annual growth rate of 8.2 percent, according to a new report from Transparency Market Research.
US regulators are preparing to revisit a now-withdrawn draft guidance on the clearance of medical devices through the 510(k) premarket notification pathway, and are looking for industry’s help in formulating a new guidance document meant to eventually take its place.
When the FDA approved Duchesnay USA’s Diclegis for morning sickness a few weeks ago, the drug became the only product available that was developed specifically for the treatment of nausea and vomiting that occurs during pregnancy, or NVP, in decades. Bendectin was on the market thirty years ago to treat NVP, but was taken off the market after the drug was linked to hundreds of lawsuits claiming that Bendectin caused birth defects, however, this turned out to be a false alarm. In 1983, the company voluntarily withdrew Bendectin.
A jury of ten in Kentucky found Advanced Bionics strictly liable and negligent for the manufacture and sale of a class III medical device, known as a cochlear implant. The jury also awarded puntiive damages against Advanced Bionics (parent company Sonova).
Workshop Dates: 28–29 September 2013
2013 RAPS Convergence Dates: 30 September –2 October 2013
Drug marketers seeking out physicians may want to consider how burned out doctors may
feel. Physicians are asked to see more patients on a limited schedule, which can lead to a hamster-on-the-wheel atmosphere. The 2013 Medscape Lifestyle Report identifies two in five of the nation’s doctors are burned out. The differences in burnout varied among specialties. In addition, health laws, private insurers, and employers will place greater demands on healthcare professionals to improve the quality of medical care and cutting costs.
SUMMARY: Each day, more than a million people in the U.S. with Type 1 diabetes juggle measuring their blood-sugar levels and administering insulin doses. Now a new generation of medical research and engineering has brought health care closer to a long-sought goal: small implantable devices that continuously monitor blood-sugar levels and administer insulin when needed. Devices that do, in effect, what a pancreas should.
The US Food and Drug Administration (FDA) would get a sizeable increase in its funding
under a new budget proposal released by the Obama Administration on 10 April 2013, but much of that funding comes in the form of user fees, reflecting some of the realities of an austere budget environment.