US regulators are preparing to revisit a now-withdrawn draft guidance on the clearance of medical devices through the 510(k) premarket notification pathway, and are looking for industry’s help in formulating a new guidance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.
As the full implementation of the Affordable Healthcare Act draws closer, shifts and
changes are taking place within the industry. Medscape has released its Physician Compensation Report 2013, which reflects that income is up, frustrations still exist, and healthcare reform is making a definite impact on physician practices. Currently, 24 percent of physicians participate in an accountable care organization, compared with 8 percent last year.
ReGen Biologics, Inc. (“ReGen”), which has been acquired by Ivy Sports Medicine, LLC (“Ivy”), filed suit in 2011 challenging FDA’s authority to rescind the 2008 510(k) substantial equivalence determination for the company’s “Menaflex” product, a collagen meniscus implant intended to reinforce damaged meniscal soft tissue. ReGen Biologics, Inc. v. Sebelius, No. 1:11-cv-01006 (D.D.C. filed May 31, 2011).
Fraudulent Versions of Botox Found in the United States: FDA is alerting health care practitioners and the public that fraudulent versions of Botox that are not approved by the FDA are being sold to U.S. medical practices. The outer carton is counterfeit, while the vial inside is labeled as a foreign version of Botox, which is not FDA-approved for sale in the United States. These products are being sold by unlicensed suppliers who are not part of the legitimate U.S. supply chain. FDA cannot confirm that the manufacture, quality, storage, and handling of these products follow U.S. standards. These fraudulent products are considered unsafe and should not be used.