In only the third such change in two decades, the FDA’s device center bids farewell to its director with the announcement that Jeff Shuren will leave the agency in the final weekend of July 2024.
The U.S. FDA literally wasted no time in posting twin warning letters to two companies in China that manufacture syringes that were the subjects of multiple recalls in the U.S.
The U.S. FDA cited Criticare Technologies Inc. for significant lapses in the company’s corrective and preventive action procedures, which suggests a need for outside certification of compliance because this problem was also observed in a warning letter from 2017.
The U.S. Patent and Trademark Office has provided updated guidance on the question of patent subject matter eligibility for inventions that rely on artificial intelligence, stating that a patent claim that does little more than recite an abstract idea is not subject-matter eligible.
Royalties for licensed patents ordinarily need not be paid after the underlying patent has expired, but the case of Zimmer Biomet Holdings Inc. v. Insall would seem to throw out a cautionary flag regarding such agreements.
Denver-based Davita Inc. agreed to pay more than $34 million to settle allegations that the company violated the Anti-Kickback Statute (AKS) by not collecting management fees from physicians to induce referrals to the company’s dialysis clinics.
The U.S. FDA’s Center for Devices and Radiological Health has rewired its organizational structure on several fronts, including a promotion of its communication function into a “super office,” which the agency said will help it be more agile and responsive to its strategic priorities.
The U.S. House Committee on Ways and Means held a field hearing in the State of Utah, during which committee chairman Rep. Jason Smith (R-Mo.), highlighted the need to continue to incentivize life science research in the U.S. Smith remarked that Republican members of the committee have formed “tax teams” to find ways that the tax code can be tweaked to “better incentivize research and development here in the U.S.,” another sign that the well-being of life science commerce is seen as a macroeconomic imperative in Washington.
The coverage with evidence development (CED) process employed by the U.S. Medicare program may suffer from underutilization, but the authors of a new article in Value in Health see the attendant problems as administrative in nature. The issues include, but are not limited to, a lack of predictability as to when a CED study would be required for coverage of a medical device.
The U.S. House Committee on Ways and Means held a field hearing in the State of Utah, during which committee chairman Rep. Jason Smith (R-Mo.), highlighted the need to continue to incentivize life science research in the U.S. Smith remarked that Republican members of the committee have formed “tax teams” to find ways that the tax code can be tweaked to “better incentivize research and development here in the U.S.,” another sign that the well-being of life science commerce is seen as a macroeconomic imperative in Washington.
