On December 11, 2020, FDA issued the first emergency use authorization (“EUA”) for a vaccine to prevent COVID-19. The vaccine, developed by Pfizer-BioNTech, is authorized for those 16 years of age and older....more
On October 22, 2020, the U.S. Food and Drug Administration (FDA) formally approved Veklury (remdesivir) as a treatment of COVID-19. Veklury, an antiviral drug, is the first treatment approved by FDA to treat COVID-19....more
Companies should use caution when making efficacy claims in marketing and advertising of dietary supplements, foods, biological products and other products purported to treat or prevent COVID-19. ...more
7/29/2020
/ Advertising ,
Biologics ,
Coronavirus/COVID-19 ,
Dietary Supplements ,
Food and Drug Administration (FDA) ,
Health Claims ,
Life Sciences ,
Marketing ,
Misleading Statements ,
Pharmaceutical Industry ,
Vaccinations
U.S. health care providers should closely inspect PPE equipment bought from Chinese companies in light of recent revelations regarding the registration practices of approximately 1,300 Chinese entities....more
Earlier last week, the US Food and Drug Administration (FDA) issued new and revised guidance on its enforcement policy for face masks, surgical masks, respirators, and face shields during the COVID-19 emergency in response to...more
Yesterday, the US Food and Drug Administration (FDA) revised its Emergency Use Authorization relating to disposable respirators made in China that are not approved by the US National Institute for Occupational Safety and...more
5/8/2020
/ China ,
Coronavirus/COVID-19 ,
Emergency Use Authorization (EUA) ,
Food and Drug Administration (FDA) ,
Imports ,
Life Sciences ,
Medical Devices ,
Medical Supplies ,
NIOSH ,
Personal Protective Equipment ,
Pharmaceutical Industry
Late last week, the U.S. Food and Drug Administration (FDA) announced it approved the use of spun synthetic swabs similar to Q-tips for use in testing for COVID-19....more
4/22/2020
/ Biologics ,
Clinical Evaluations ,
Clinical Laboratories ,
Clinical Laboratory Testing ,
Clinical Trials ,
FDA Approval ,
Food and Drug Administration (FDA) ,
Good Clinical Practices ,
Life Sciences ,
Medical Devices ,
Pharmaceutical Industry ,
Product Labels ,
Virus Testing
The US Food and Drug Administration (FDA) is prioritizing the development and review of new therapies to treat COVID-19 through a recently created special emergency program titled Coronavirus Treatment Acceleration Program...more
4/10/2020
/ Applicable Manufacturers ,
Biologics ,
Breakthrough Therapy Designation ,
Coronavirus Treatment Acceleration Program (CTAP) ,
Food and Drug Administration (FDA) ,
Generic Drugs ,
Intellectual Property Protection ,
Life Sciences ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prescription Drugs
To address critical shortages of blood and plasma during the COVID-19 pandemic, the U.S. Food and Drug Administration (the “FDA”) released several guidance documents on April 2, 2020. ...more