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
FDA recently revoked a multi-month Emergency Use Authorization (the EUA) for use of chloroquine and hydroxychloroquine as an experimental treatment for patients suffering from COVID-19. ...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
Today, the U.S. Patent and Trademark Office announced a pilot program to accelerate prosecution of patent applications relating to COVID-19 prevention and treatment submitted by small and micro entities. ...more
The U.S. Food and Drug Administration has provided guidance for health care professionals to use convalescent blood plasma from patients who have recovered from COVID-19 as a potential treatment for currently infected...more
The U.S. Food and Drug Administration has permitted limited use of the antimalarial drugs hydroxychloroquine and chloroquine in the treatment of COVID-19 since issuing an Emergency Use Authorization for such drugs on March...more
Convalescent blood plasma from patients who have recovered from COVID-19 is a potential treatment that has gained scientific interest. Because COVID-19 convalescent plasma has not yet been approved by FDA, it is regulated as...more
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 Food and Drug Administration has taken many steps to assist in the response to the COVID-19 health crisis, including easing regulations, expediting the availability of necessary medical equipment, and creating streamlined...more
In mid-March, the US Food and Drug Administration announced via press release an “unprecedented policy” to increase testing capacity for COVID-19 in the United States. As part of its Policy for Diagnostic Tests for...more
4/17/2020
/ Centers for Medicare & Medicaid Services (CMS) ,
CLIA ,
Clinical Laboratories ,
Coronavirus/COVID-19 ,
Diagnostic Tests ,
Emergency Use Authorization (EUA) ,
FDA Approval ,
Food and Drug Administration (FDA) ,
Guidance Update ,
Laboratory Developed Tests ,
Legislative Agendas ,
Proposed Legislation ,
Public Health Service Act ,
Regulatory Oversight
Along with the US Food and Drug Administration’s guidance addressing shortages of masks and respirators, FDA has released guidance aimed at increasing the supply of other personal protective equipment important in the fight...more
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
The US Food and Drug Administration (FDA) issued updated guidance superseding its earlier March 25, 2020, “Enforcement Policy for Face Masks and Respirators During the Coronavirus Disease (COVID-19) Public Health Emergency...more
4/8/2020
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
In response to the shortage of alcohol-based hand sanitizer due to the COVID-19 pandemic, distillers and other entities that manufacture alcohol have stepped in to assist in the production of alcohol-based hand sanitizer. On...more
The Coronavirus Aid, Relief, and Economic Security Act ("CARES Act") allows the United States Patent and Trademark Office (USPTO) to extend the time to file certain patent-related documents or fees. Specifically, subsection...more
Starting in February 2020, the US Food and Drug Administration (the “FDA”) began using its Emergency Use Authorization (“EUA”) powers under Section 564 of the Federal Food, Drug, and Cosmetic Act (“FD&C”) to allow unapproved...more
4/2/2020
/ 3D Printing ,
Coronavirus/COVID-19 ,
Emergency Use Authorization (EUA) ,
FDA Approval ,
Food and Drug Administration (FDA) ,
Healthcare ,
Medical Devices ,
Medical Supplies ,
Personal Protective Equipment ,
Pharmaceutical Industry ,
Prescription Drugs
On March 24, 2020, the US Food and Drug Administration (“FDA”) issued Guidance[1] suspending the enforcement of certain veterinarian-client-patient relationship (“VCPR”) requirements to help veterinarians provide animal...more
4/1/2020
/ Animal Drugs ,
Animal Food ,
Animal Health ,
Antibiotics ,
Distributors ,
Food and Drug Administration (FDA) ,
Food Safety ,
FSMA ,
Manufacturers ,
New Regulations ,
Notice Requirements ,
Recordkeeping Requirements ,
Telemedicine ,
Veterinarians ,
Veterinary Products
The U.S. Food and Drug Administration (the “FDA”) issued Guidance[1] on March 22, 2020 to continue its efforts to maintain an adequate supply of devices to treat patients who develop respiratory failure or respiratory...more
3/27/2020
/ Draft Guidance ,
Enforcement ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Healthcare ,
Labeling ,
Manufacturers ,
Medical Devices ,
Product Labels ,
Public Health ,
Required Communications
From severe shortages in medical masks and ventilation equipment worldwide to the curious “toilet paper desert” in America, COVID-19 is creating temporary and long-term disruptions in the availability of both highly...more
3/25/2020
/ Advertising ,
Consumer Protection Laws ,
Cosmetics ,
Departments of Commerce ,
Enforcement Actions ,
False Advertising ,
FDA Warning Letters ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Federal Trade Commission (FTC) ,
Food and Drug Administration (FDA) ,
Hemp ,
Influencers ,
Labeling ,
Pending Legislation ,
Personal Care Products ,
Supply Chain