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.…
AstraZeneca has nabbed an HHS contract worth up to $1.2 billion to speed development and production of the University of Oxford’s promising COVID-19 vaccine candidate. The deal also would lock…
TriNetX is partnering with the FDA’s Sentinel Operations Center at the Harvard Pilgrim Health Care Institute (HPHCI) to monitor priority drugs used for treating hospitalized COVID-19 patients. Source: Devices &…
Enrollment for a large, global trial of chloroquine and hydroxychloroquine for the prevention of COVID-19 is getting under way in the United Kingdom. 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 device should be available in Europe, Australia and New Zealand in June. Source: Devices & Diagnostics Letter
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 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