FDA COVID-19 Treatment Approval

First FDA Approval for COVID-19: Veklury (remdesivir), an antiviral drug, manufactured by Gilead. It is for use in adult and pediatric patients 12 years of age and older and weighing at least 40 kilograms (about 88 pounds) for the treatment of COVID-19 requiring hospitalization. 

The FDA granted Gilead’s application Fast Track and Priority Review designations. Further FDA granted this application a  Material Threat Medical Countermeasure Priority Review Voucher. This means additional incentives because COVID-19 falls within this category; that is, medical products intended to treat or prevent harm from specific chemical, biological, radiological and nuclear threats. It is important to mention that this approval does not include the entire population that had been authorized to use Veklury under an Emergency Use Authorization (EUA) (issued on May 1, 2020). 

NOTE—FDA had granted Gilead Sciences Orphan Drug status for remdesivir and orphan designation for the “Treatment of coronavirus disease 2019 (COVID-19)” (March 23, 2020) which means tax advantages and exclusivity; however, in an unusual twist,  Gilead requested on March 25, 2020 that FDA rescind orphan drug designation.

https://www.fda.gov/news-events/press-announcements/fda-approves-first-treatment-covid-19

https://www.gilead.com/news-and-press/press-room/press-releases/2020/10/us-food-and-drug-administration-approves-gileads-antiviral-veklury-remdesivir-for-treatment-of-covid19

COVID-19, CBD, VAPING, PET PRODUCTS SAFETY, OPIOID EPIDEMIC

This week, on Wednesday October 21, from 1-4pm, the FDLA, Delaware Law will be virtually hosting its “All Matters FDA” Symposium which will host a variety of speakers from professors, to judges, to other professionals in the field to discuss a range of topics such as: opioids and pharmaceuticals, COVID-19, vaping, cannabis law, and pet products. Just follow the link below to register. Even if you can only attend in part we hope you will be able to join us!   If you register and have a conflict the session will be recorded.

The Symposium will be hosted over zoom, and a link will be sent out beforehand.

Even if you can only attend in part we hope you will be able to join us!   If you register and have a conflict the session will be recorded.