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
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 combat shortages of N95 respirators, the Centers for Disease Control and Prevention issued and continues to update its Strategies for Optimizing the Supply of N95 Respirators. The CDC’s N95 Respirator Strategies provide...more
4/7/2020
/ Best Practices ,
Biologics ,
Centers for Disease Control and Prevention (CDC) ,
Coronavirus/COVID-19 ,
Crisis Management ,
Emergency Management Plans ,
Face-Filtering ,
Health and Safety ,
Healthcare ,
Hospitals ,
Infectious Diseases ,
Medical Devices ,
Medical Supplies ,
OSHA ,
Personal Protective Equipment ,
Policies and Procedures ,
Public Health ,
Risk Management ,
Workplace Safety
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
The Hatch-Waxman Act was enacted in 1984 to address two main congressional goals: (1) to encourage innovation in pharmaceutical research and development; and (2) to help generic drugs reach the market more quickly. Through...more
3/16/2018
/ Abbreviated New Drug Application (ANDA) ,
Biologics ,
Biosimilars ,
Food and Drug Administration (FDA) ,
Generic Drugs ,
Hatch-Waxman ,
Intellectual Property Protection ,
Life Sciences ,
Patent Infringement ,
Patent Litigation ,
Patent-in-Suit ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prescription Drugs