Ogenix has received a warning letter from the U.S. Food and Drug Administration related to its Epiflo oxygen therapy medical device for wound healing.The FDA’s warning letter details six specific violations uncovered during an inspection of the Florida-based company’s manufacturing facility in Beachwood, Ohio.Most of the violations deal with issues that involve documentation and record [...]

Mark DuVal’s practice is going gangbusters.The Twin Cities regulatory attorney has been in practice since 1986, initially with 3M Pharmaceuticals and later with its medical device businesses before moving on to Medtronic, where he was director of corporate regulatory issues and compliance for two years. In 2003, DuVal went into business for himself by setting [...]

As the basketball frenzy that accompanies March Madness draws to the fever pitch of the Final Four, it brings to mind that basketball is a high contact sport. A quick peek at the NBA injured list reveals a catalog of breaks and tears that affect tendons, ligaments and bones.The pressure to improve performance and search [...]

The head of a stem cell company has responded to a warning letter issued by the U.S. Food and Drug Administration that cites several violations at the company that derives stem cells from adipose tissue or body fat.Dr. Steven Victor of IntelliCell BioSciences said it would be moving to a new facility next month that [...]

Spinal device company Lucero Medical has received a warning letter from the U.S. Food and Drug Administration, primarily over documentation and quality-control issues.Hinckley, Ohio-based Lucero produces a cylindrical-shaped, titanium mesh device that’s implanted in the spine to replace collapsed or diseased vertebrae. The device, called the Enduramesh, is designed to aid in spinal fusion.The warning [...]

A warning letter issued by the U.S. Food and Drug Administration has cited numerous violations by a stem cell company and claimed it did not have an appropriate license to produce stem cells.IntelliCell BioSciences in New York derives stem cells from adipose tissue, or fat cells, for treatments ranging from lower back pain to cosmetic [...]

The U.S. Food and Drug Administration issued new guidelines Tuesday to help device makers understand how FDA reviewers evaluate premarket approval for high-risk devices and de novo submissions for moderate risk devices.In doing so, the agency reiterated a desire to provide clarity, consistency and transparency to a process that device manufactures have often charged as [...]

Cetero Research, the clinical research organization that fell under regulatory scrutiny for allegedly falsifying clinical trial data, has filed for bankruptcy protection.The U.S. Food and Drug Administration last July disclosed its inquiry into Cary, North Carolina CRO Cetero, which raised concerns over data and test results over a five-year period. The agency said that pharmaceutical [...]

Professors Lisa Schwartz and Steven Woloshin of the Center for Medicine and the Media at The Dartmouth Institute for Health Policy and Clinical Practice are raising alarms about a recent Food and Drug Administration decision to approve a new dosage for the best-selling Alzheimer’s drug Aricept (donepezil). The decision “breached the FDA’s own regulatory standard” [...]

Two months after a regulatory panel recommended the approval of the Linx Reflux Management System, the U.S. Food and Drug Administration approved the minimally invasive device developed by Torax Medical of Shoreview, Minnesota to treat acid reflux. In announcing the premarket approval Thursday, the FDA said that Torax will “institute a required training program [...]