Category: Regulations
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Radio Chips Found Effective in Tracking Surgical Sponges
A study of simulated surgical procedures found surgical sponges with embedded radio-frequency (RF) chips were detected when placed out of visual sight under the patients, many of whom were obese. The findings appear in the February issue of The American Journal of Surgery (paid subscription required). Retained surgical items — those left in the patient’s…
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Brain Shown to Have Opposite Reactions to Fructose, Glucose
New research on the brain’s reactions to two kinds of sugars offers insights into the way people find some sugary foods so inviting. The results are published in the current online edition of the journal Diabetes, Obesity and Metabolism (paid subscription required). Researchers from Oregon Health and Science University in Portland and University of California…
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Nursing Home Liquid, Cream, Inhaler Drug Error Rates Higher
A study in British nursing homes finds wide variations in medicinal delivery error rates depending on the formulation and type of delivery system. The results are published in the online edition of the journal BMJ Quality and Safety (paid subscription required). The research team from University of Leeds, University of London, and the London School…
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FDA Clearance Granted for Blood Tissue Monitor
Ornim Inc. in Santa Clarita, California said it received clearance from the U.S. Food and Drug Administration (FDA) to market its the CerOx 3210F monitor. The FDA action, known as a 510(k) clearance, is a pre-market notification required for medical devices to be sold in the U.S. Ornim says the FDA action clears the CerOx…
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FDA Blocks Obesity Drug Over Cardiac Concerns
The U.S. Food and Drug Administration (FDA) has told Orexigen Therapeutics Inc. in San Diego, California and Takeda Pharmaceutical Company Limited in Osaka, Japan that the agency is withholding approval of the companies’ candidate obesity management drug Contrave pending results of another clinical trial to address risks of heart disease. The companies released excerpts from…
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FDA Approves Trial of Nanotech Cancer Cell Markers
The U.S. Food and Drug Administration (FDA) has approved the first clinical trial in humans of brightly glowing nanoparticles to light up cancer cells to aid in diagnosing and treating cancer. The trial with five melanoma patients at Memorial Sloan-Kettering Cancer Center (MSKCC) in New York City will test if the technology is safe and…
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Pathology Lab, Institute Partner on Cancer Drug Services
Flagship Biosciences, a pathology lab in Flagstaff, Arizona and TGen Drug Development (TD2), in Scottsdale, Arizona, have teamed up to provide drug discovery and development services to cancer researchers. Flagship Biosciences is a pharmaceutical services company that offers digital pathology to test diseased tissue samples for biotech, pharmaceutical, and medical device customers. TD2 is a…
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Orphan Drug Status Granted for Melanoma Vaccine
BioSante Pharmaceuticals Inc. said today it received from the U.S. Food and Drug Administration orphan drug designation for its melanoma cancer vaccine to treat stage IIb to IV melanoma. BioSante Pharmaceuticals is a specialty pharmaceutical company in Lincolnshire, Illinois. Orphan drug designation, as granted by the Orphan Drug Act, is for a product to treat…
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FDA Plans Update of Medical Device Review Process
The U.S. Food and Drug Administration (FDA) has released a plan with 25 actions it intends to implement in 2011, which it says will improve the path to market for many medical devices. The new procedures affect the “510(k) process,” named for the section of FDA’s enabling legislation that applies to medical device approval. Before…
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Study: Longer Drug Exclusivity Hikes Costs, Adds Approvals
A new study in the January 2011 issue of the journal Health Affairs (paid subscription required) calculates the financial and social costs of regulations that limit access to pharmaceutical companies’ clinical trial data, used in the manufacture of generic drugs. The study suggests that extending the term of exclusive access for that data would likely…