Archive for May 2020
FDA Adds Morphine, Epinephrine to COVID-19 Compounding List
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. Source: Devices & Diagnostics Letter
Read MoreAstraZeneca Receives $1.2 Billion BARDA Contract for COVID-19 Vaccine
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 in the distribution of 300 million doses of the vaccine for the U.S. Source: Devices & Diagnostics Letter
Read MoreTriNetX, Harvard Pilgrim Health Care Institute to Monitor COVID-19 Drug Usage
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 & Diagnostics Letter
Read MoreLarge Hydroxychloroquine Study Gets Under Way
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
Read MoreFujifilm Begins Research on AI Tech for COVID-19 Pneumonia
The company is involving local Japanese medical institutions in its project, beginning with Yokohama’s Kanagawa Cardiovascular and Respiratory Center. Source: Devices & Diagnostics Letter
Read MoreBaxter Earns CE Mark for Syringe-Infusion System
The device should be available in Europe, Australia and New Zealand in June. Source: Devices & Diagnostics Letter
Read MoreBioMérieux’s COVID-19 Antibody Tests Obtain CE Mark
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
Read MoreNew Jersey Contract Tester Warned for API Testing Violations
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
Read MoreEurope’s MDCG Releases Guidance on Class 1 Transitions Under MDR
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
Read MoreFDA Wants Proof of Reliability for Emergency-Use Injectors
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
Read More