The Department of Agriculture's Food Safety and Inspection Service will continue its inspections of the country's 6,200 meat and poultry slaughter and processing plants in spite of the government shutdown. Meat, egg, poultry and catfish production in the US would come to a halt and products could not be exported or sold without the required USDA inspection.
A public meeting will be held next week by the FDA regarding its intention to promote a reduced-risk tobacco product called iQOS, which heats tobacco rather than vaporizing nicotine-containing liquid. The review of iQOS is part of a two-part plan by the FDA to review cigarette alternatives and cut the amount of nicotine in cigarettes.
A priority review status was granted by the FDA to Genmab's daratumumab, which is being developed as a first-line treatment for patients with multiple myeloma. The agency's action date for daratumumab is May 21.
A draft guidance on transparency of information related to drug application review and approval was issued by the China FDA. The guidance requires the agency to disclose, via a public drug trial center portal, information on the acceptance, review, approval process and the result of the review of every application, with the portal creating a review system to decide what information will be made public and what should be kept confidential.
The FDA granted Centric Medical 510(k) clearance for its Cannulated Screw Internal Fixation System to be used in foot and ankle reconstruction procedures. The streamlined multicomponent system, which is made of titanium alloy, comes in various diameters and lengths with new options for the forefoot.
The Lightning-enabled version of the Dario blood glucose monitoring system was launched by DarioHealth in Australia. The system is intended to connect to Apple's iPhone 7, 8 and X smartphones.
An FDA-cleared pivotal study of the VasQ implanted blood vessel device, designed for patients who need arteriovenous fistulas as vascular access for hemodialysis, was launched by Israel-based Laminate Medical Technologies. The prospective, multisite trial will follow 129 patients for up to two years, with primary patency rate at six months after fistula creation as its primary effectiveness endpoint.
HealthCare Royalty Partners and EA Pharma paid Albireo Pharma's Elobix subsidiary approximately $55 million after Japan's Ministry of Health, Labor and Welfare approved Goofice, or elobixibat, which is indicated to treat chronic constipation.
- Page 1