Moving remote: the post-pandemic clinical trial

by | Sep 23, 2020 | Uncategorized

By Lucy Fulford on Apr 3, 2020 / https://www.reutersevents.com/ The restrictions on movement and normal interaction owing to COVID-19 pose a distinct challenge to the traditional clinical trial model, as patients, investigators and clinical staff are either confined...

Emergency Use Authorization (EUA)

by | Sep 21, 2020 | Uncategorized

As a result of the Coronavirus Disease 2019 (COVID-19) pandemic and under the authority of section 564 of the Federal Food, Drug, and Cosmetic (FD&C) Act, the FDA has issued numerous Emergency Use Authorizations (EUAs) for medical devices intended to...

eMDR System Enhancements

by | Sep 18, 2020 | Uncategorized

In a recent bulletin, FDA communicated that updates to the eMDR previously announced in May 2020 were complete. The changes include: The addition of new fields for exemption number, summary report, number of events and combination products.An updated list of device...
Work with Employees Before Re-Opening

Work with Employees Before Re-Opening

by | Jun 1, 2020 | Pharma, Uncategorized

from: https://www.ehstoday.com/ Communication is key to the re-opening process, and helping employers get over fear of messing up. With all of the confusion surrounding different states’ decisions over the re-opening of businesses shut down because of the Coronavirus...