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Passage of a US FDA diagnostics reform bill is one priority for the US House Energy and Commerce Committee in 2019, said cosponsor and committee member Rep. Diana Degette, D-Colo.
Latest From United States, Policy & Regulation
AdvaMed has revised its industry Code of Ethics. The revised code, which will come into effect in 2020, includes new sections on off-label communications and training health-care professionals to use new medical technology.
The number of direct-to-consumer advertisements for molecular-based tests rose exponentially from 1997 to 2016, according to a medical marketing analysis released earlier this month in the Journal of the American Medical Association. Simultaneously, laboratory test manufacturers increased spending on ads and direct spending on physicians who work with the tests from $75.4m to $82.6m.
US FDA has about three months' worth of medical device carryover user-fee funds to burn if the partial federal government shutdown continues, although the agency is still finalizing its shutdown balance sheet, Commissioner Scott Gottlieb says.
Several experts suggest FDA is toeing the line in keeping the first stage of its pre-certification program for software-as-a-medical-device products legally permissible, but it may be limited in scope for the time being. Meanwhile, one attorney says the agency is sending mixed messages about whether the current program will sit comfortably within FDA's current authorities.
In setting his agenda for the US Senate Finance Committee in 2019, incoming Chairman Chuck Grassley, R-Iowa, says he will continue to cosponsor bills to end the device tax, focus on lowering prescription drugs and other medical product health-care costs, expand tax breaks for business, and make sure Congress has a strong hand in negotiating trade and tariff talks.
In 2019, FDA will be taking steps to perform real-world testing of the effectiveness of its pre-cert program for health software and whether the program can be carried out within the agency's current regulatory authorities. The efforts come after more than a year of development and some pushback about statutory overreach and patient safety.
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