FDA Gives Guidance on Bioequivalence Studies for Submission Amidst Covid
The FDA released guidance on Tuesday (4/28) for bioequivalence studies intended for submission in Abbreviated New Drug Applications (ANDAs). Due to Covid, many clinical trial studies have been negatively impacted due to travel limitations, site closures, etc. With...
EU Gives Five New Guidances for Medical Devices
The European Commission's Medical Device Coordination Group (MDCG) posted five new guidances on Friday (4/24) for medical devices in light of COVID-19. These guidances are used when demonstrating equivalence to existing devices,...
EU Unanimously Votes to Delay EU MDR by 1 Year
In a unanimous decision on Wednesday (4/22), the European Union has decided to push back the amendment to the EU MDR by one year amidst the COVID-19 pandemic. This extra time will allow more time to ensure the functionality and design of the new system, while also...
FDA Authorizes First At-Home Covid Testing Kits
Yesterday (4/21) the FDA announced EUA for at-home Covid testing kits from LabCorp. These nasal swab tests were previously authorized in mid-March by the FDA, however only for medical professionals to use. Stephen Hahn, FDA Commissioner, released in a statement that...
MemorialCare Long Beach Center Joins Global Fight Against Covid
As part of an ongoing global study, MemorialCare Long Beach Center has administered the antiviral drug Remdesivir to three patients as a possible treatment for Covid. This news comes closely after Gilead, a biotech company based out of the California Bay Area,...
FDA Allows Outsourcing for Drugs in Short Supply Due to Covid
The FDA announced on Thursday (4/16) it was temporarily allowing compounding for necessary hospital drugs due to the mass shortage from Covid. The majority of the 13 commonly used drugs listed in the policy are anesthetic or analgesic drugs, which helps support...