US regulators’ plans to share data, quickening the medical product approval process, have met with a lukewarm reception. Thomas Novelli of the Medical Device Manufacturers Association explains to Rhian Owen why the FDA and CMS’ proposed ‘parallel review’ process is attempting to solve more issues than it can handle.
Delays and changes in the device approval process in the US are causing concern among manufacturers and patients. Thomas Novelli of the Medical Device Manufacturers Association asks whether the US can continue to maintain its position as the global leader of innovative medical technologies.
Medical device companies marketing their products in overseas markets face many challenges. Companies should be aware of the new attitude of regulators to actively pursue violators and take steps to ensure good compliance with all aspects of the Foreign Corrupt Practices Act, writes Thomas Novelli, Medical Device Manufacturers Association.
The FDA’s recall and labelling authority has come under criticism from members of Congress. They are questioning its willingness to approve or clear new medical devices for use in the US. Thomas Novelli of the Medical Device Manufacturers Association, examines the agency’s system and asks is it time for a change?
Device tax, new regulations and effectiveness research are causing some panic among medical manufacturers in the US. Will the industry be able to weather these changes? Thomas C Novelli of the MDMA investigates.
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The medical and pharma industries are waiting to hear the results of the main US review of advertising procedures. With concerns over false information rife, Thomas C Novelli of the MDMA looks at what changes are likely to be proposed and their anticipated consumer and industry effects.
Copying, counterfeiting and lack of property rights have made the West wary of working with Chinese manufacturers. However, all that could change as legislation becomes more strict and countries work together. Meanwhile, the US and EU are seeing regulatory changes of their own, explains Thomas C Novelli of the MDMA.
How will the election of President Barack Obama in the US affect medical care globally? Thomas C Novelli of the MDMA looks at policy and reforms over issues such as comparative effectiveness, transparency and payment options.
Can medical innovation fight back against the pressures of funding and patent protection? Thomas C Novelli of the MDMA investigates the latest regulations to help manufacturers continue producing new technologies.