SAN JOSE, Costa Rica – Two decades ago, the Costa Rican economy was basically an agriculture-based economy. Since then, the tiny Central American country has emerged as the second-largest med-tech exporter in the region as well as an eager partner and supplier of skilled manpower.
The U.S. FDA has finalized two guidances dealing with class II tests that are subject to Medicare regulations, including the so-called dual CLIA waiver guidance. The agency said it will hold an April 14, 2020, webinar to go over both guidances, allocating 90 minutes to deal with questions about the two documents.
LONDON – It was third time lucky for Acacia Pharma Group plc, as the FDA finally gave approval to Barhemsys (amisulpride) as a rescue treatment for surgical patients suffering postoperative nausea and vomiting (PONV), despite standard-of-care treatment.
The second day of the FDA workshop on artificial intelligence (AI) in health care featured several interesting proposals, including that AI will be used in health care without the aid of a health care professional. John Martin, chief medical officer at Butterfly Network Inc., of Guildford, Conn., said the time is ripe for AI-assisted ultrasound in the home, which he claimed could reduce rehospitalizations in heart failure, one of the holy grails in U.S. government efforts to restrain health care spending growth.
Citing what it called poor study design and execution coupled with a lack of follow-up data, the FDA’s Oncologic Drugs Advisory Committee voted 13-2 against recommending approval of Steba Biotech SA’s NDA for Tookad (padeliporfin dipotassium) for injection in men with localized early stage prostate cancer.
While the staff at the U.S. Department of Health and Human Services (HHS) is currently all hands-on-deck in responding to the COVID-19 outbreak, some of the agencies in the department may have to divert resources to get sponsors of drug and device clinical trials to fill in nearly a decade-long data gap on Clinicaltrials.gov. That’s if a judge’s decision handed down this week stands.