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ReWalk Robotics announces the Appointment of Randel E. Richner, BSN, MPH to its Board of Directors

The Pharma Data

Richner received a Master of Public Health in Health Policy and Administration and a Bachelor of Science in Nursing from the University of Michigan in Ann Arbor, Michigan. develops, manufactures and markets wearable robotic exoskeletons for individuals with lower limb disabilities as a result of spinal cord injury or stroke.

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Article FDA Thank You In a new final rule, FDA carves out a regulatory niche for medical gases

Agency IQ

In 2001, the FDA issued a guidance to “alert hospitals, nursing homes, and other health care facilities to the hazards of medical gas mix-ups.”

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FDA and Off-Label Communication – Getting Closer to Truth

Drug & Device Law

341 (2001)), calls “off-label use,” so we go with the majority naming convention. T]hese marketing techniques influence use of the products based on elements other than the scientific content of the communication (as used herein, “persuasive marketing techniques”). Plaintiffs Legal Committee , 531 U.S.

FDA 64
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PMA Preemption Decision Slides to the Bottom of the “Parallel Claim” Slippery Slope

Drug & Device Law

312 (2008), that essentially all product liability claims against manufacturers of FDA pre-market approved (“PMA”) medical devices were preempted. That’s a toxic mix, indeed, when combined with the plaintiffs’ bar’s latest concerted attempt to drive a form of birth control off the market through product liability litigation.

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A Painful Preemption Decision

Drug & Device Law

341, 352 (2001) (“neither an express pre-emption provision nor a saving clause bars the ordinary working of conflict pre-emption principles”). This regulation specifies the precise language for “liver”-related warnings on acetaminophen-containing products marketed for adult use. Buckman Co. Plaintiffs Legal Committee , 531 U.S.