The FDA added morphine sulfate and epinephrine to the list of compounded drugs under the agency’s temporary policy that allows outsourcing facilities to produce the drugs during the COVID-19 pandemic.…
The presence of antibodies in a patient means that they likely had COVID-19 at some point and may suggest they have some degree of immunity. Source: Devices & Diagnostics Letter
The device should be available in Europe, Australia and New Zealand in June. Source: Devices & Diagnostics Letter
The company is involving local Japanese medical institutions in its project, beginning with Yokohama’s Kanagawa Cardiovascular and Respiratory Center. Source: Devices & Diagnostics Letter
The FDA hit a Paterson, New Jersey contract testing laboratory with a warning letter for active pharmaceutical ingredient (API) testing violations. Source: Drug Industry Daily
The EU’s Medical Device Coordination Group released a guidance for devicemakers on transitional provisions for Class I devices under the Medical Device Regulation (MDR). Source: The GMP Letter
The FDA said sponsors of emergency-use injectors should include details in their marketing applications to show that the devices are reliable. Source: The GMP Letter
Australia’s Therapeutic Goods Administration (TGA) fined Oxymed Australia A$63,000 ($40,000) for making false claims that its hyperbaric oxygen therapy chambers can treat a variety of conditions, including COVID-19. Source: The…
The FDA cited six U.S. devicemakers for a variety to quality failures including failing to submit medical device reports or to maintain a device master record. Source: The GMP Letter
To expand their availability during the pandemic, the FDA has temporarily relaxed its regulations on the use of certain digital pathology devices in laboratories. Source: The GMP Letter