On Jan. 15, 2021, the U.S. Department of Health & Human Services (HHS) issued a notice, “Making Permanent Regulatory Flexibilities Provided During the COVID-19 Public Health Emergency by Exempting Certain Medical Devices From...more
On Dec. 11, the U.S. Food and Drug Administration (FDA) issued the first emergency use authorization (EUA) for a vaccine for the prevention of the coronavirus disease 2019 (COVID-19). An EUA differs from an approval in that...more
This update approaches three months of coverage of the Food and Drug Administration (FDA) and related regulatory response to COVID-19. Updates and developments continue in the COVID-19 response despite a decrease in media...more
Efforts to increase testing are occurring at the national and state levels. The Food and Drug Administration (FDA) continues to crack down on firms marketing products – including drugs, testing kits and personal protective...more
With this update, we have covered and provided Food and Drug Administration (FDA), Drug Enforcement Administration (DEA), and state boards of pharmacy actions related to COVID-19 for more than one month. This update will...more
The medical device industry and the Food and Drug Administration (FDA) have been experimenting with three-dimensional (3D) printing for years. Shortages of medical devices such as personal protective equipment (PPE) and...more
Multiple regulatory agencies continue to do their part in the fight against COVID-19. This week, the U.S. Drug Enforcement Administration (DEA) and Food and Drug Administration (FDA) and state boards of pharmacy all acted to...more
Shortages of gloves, gowns, face masks, respirators, ventilators, drugs and hand sanitizer continue to be reported. The crackdowns on prescribing of chloroquine and hydroxychloroquine, currently being studied to treat...more
In response to the COVID-19 outbreak in the United States, the Food and Drug Administration (FDA) has issued an increasing number of EUAs, now in the double digits, for in vitro diagnostic (IVD) products and personal...more
The U.S. now has the most confirmed coronavirus cases in the world, and the FDA and state boards of pharmacy are issuing daily guidance on how to stop the spread or join in the fight through relaxed standards or expedited...more
3/30/2020
/ Coronavirus/COVID-19 ,
Emergency Use Authorization (EUA) ,
Food and Drug Administration (FDA) ,
Food Labeling ,
Food Safety ,
Manufacturers ,
Medical Devices ,
Personal Protective Equipment ,
Pharmaceutical Industry ,
Pharmacies ,
Restaurant Industry ,
Veterinarians
Hand sanitizer, critical infrastructure, drug shortages and Emergency Use Authorizations (EUAs) are the FDA updates on COVID-19 over the weekend....more
Here, we provide you with the first update to important actions in the life sciences sector that the Food and Drug Administration (FDA) and state boards of pharmacy are taking to address the pandemic so far. ...more
The new coronavirus continues to be the leading global news headline. We have established a comprehensive online resource center to help address and answer legal questions about coronavirus disease 2019 (COVID-19). ...more