Are you sure you'd like to remove this alert? You will no longer receive email updates about this topic.
Latest From Sue Darcey
Among Stephen Hahn’s priorities and long-term ambitions for his time at the US agency are retaining and recruiting the best possible professional staff, and collection and use of data, regulatory consultants and attorneys say.
Bioresearchers at the Centers for Disease Control and Prevention are hoping that diagnostic platforms previously used to develop tests for outbreaks of other epidemic respiratory diseases, including SARS and MERS, can be built on to develop new diagnostics to detect more cases in the current coronavirus outbreak, US infectious disease authorities say. This comes as more patients are monitored around the US for the disease, and a Chicago woman returning from China tests positive.
FDA ‘Stands Ready’ To Fight Coronavirus Via Emergency-Use Test Kits While WHO Mulls Virus Spread, Gets Out Guidance
The US Food and Drug Administration (FDA) stands poised to proceed with hastened approvals for 2019-coronavirus (nCoV) diagnostics, treatments and vaccines, if a public health emergency is declared, after an infected US traveler who caught the disease in Wuhan, China returned from the province to Washington State. Spread of the disease has reached a crisis level in China, and the World Health Organization met on 22 and 23 January to consider what actions to take to contain the virus, while issuing an interim laboratory test guidance for use in diagnosing the disease.
The US Senate overwhelmingly approved a bill on 16 January to implement the US-Mexico-Canada agreement, which includes a new chapter on the handling of medical devices supported by the medtech industry.
The Agency for Healthcare Research and Quality (AHRQ) is conducting a review on treatments for acute pain and is asking device manufacturers and other organizations to supply it with studies on nonpharmacological therapies to control pain, including transcutaneous electrical nerve stimulation, ultrasound, heat- and cold-producing devices, and acupuncture.
Brad Smith, the former CEO of Aspire Health, a home-based palliative-care company, was appointed director of the Center for Medicare and Medicaid Innovation (CMMI) at the US Medicare agency CMS.