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Cardinal Health received an FDA Warning Letter because the company is marketing Monoject convenience kits that include 3 mL, 10 mL, and 20 mL piston syringes and control syringes made by Chinese manufacturer Jiangsu Shenli Medical Production. Read More
This week, the FDA announced a Medical Devices Advisory Committee meeting, availability of a report on postmarketing performance of drug firms, revised draft guidance on biologic promotional labeling and advertising, three draft guidances on cancer clinical trial eligibility criteria, and a request for comments on promoting effective drug development. Read More
Inadequate responses to the findings of an October 2023 FDA inspection of Royal Philips’ Suzhou, China, facility has earned the company a Warning Letter citing the risks of malfunctioning of cable connection failure and software defects. Read More
With an aim of supporting patients, medical device developers and policymakers, the CDRH has launched a new initiative to deliver virtual reality-enabled models for use in the development of home-based care solutions. Read More
Exactech has initiated a recall to remove Equinoxe shoulder system devices packaged in defective bags from facilities’ unused inventory the FDA announced in an update of its Jan. 16 safety communication on the products. Read More
As the second session of the 118th Congress begins, FDAnews will track important pending legislation, that has been acted on since Oct. 1, 2023 to keep you updated on laws and regulations that could impact your business. Read More
The Department of Justice (DOJ), HHS and the FTC have jointly launched a public-facing portal for reporting unfair and anticompetitive practices that the Biden administration says will support its efforts to lower healthcare and prescription drug costs. Read More