Jamaica Potts Szeliga on Food and Drug Administration (FDA)

FDA Issues Emergency Use Authorization for COVID-19 Vaccine

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

12/15/2020 / Coronavirus/COVID-19 , Emergency Use Authorization (EUA) , FDA Approval , Food and Drug Administration (FDA) , Infectious Diseases , Life Sciences , Pfizer , Public Health Emergency , Vaccinations

FDA Approves Veklury (remdesivir) As The First Treatment For COVID-19

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

10/27/2020 / Coronavirus/COVID-19 , FDA Approval , Food and Drug Administration (FDA) , Infectious Diseases , Life Sciences , Pharmaceutical Industry , Prescription Drugs , Research and Development

FDA Aggressively Monitoring and Pursuing Advertisements Touting Treatments, Preventions and Cures for COVID-19

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

Chinese Manufacturers of Personal Protective Equipment Gave False U.S. Agent Information to Food and Drug Administration

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

6/26/2020 / China , Coronavirus/COVID-19 , FDA Approval , Food and Drug Administration (FDA) , Life Sciences , Medical Supplies , Personal Protective Equipment , Pharmaceutical Industry , Registration Requirement , Supply Chain

FDA Revokes Emergency Use Authorization For Highly Watched Chloroquine and Hydroxychloroquine - But They Can Still Be Prescribed

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

6/22/2020 / Coronavirus/COVID-19 , Emergency Use Authorization (EUA) , FDA Approval , Food and Drug Administration (FDA) , Medical Supplies , Pharmaceutical Industry , Prescription Drugs

FDA Revises Guidance on Face Masks, Respirators, and Face Shields to Address Covid-19 Concerns

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

6/1/2020 / Coronavirus/COVID-19 , Emergency Use Authorization (EUA) , Food and Drug Administration (FDA) , Health Care Providers , Healthcare Workers , Life Sciences , NIOSH , Personal Protective Equipment , Workplace Decontamination

FDA Updates Emergency Use Authorization For Chinese Respirators

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

FDA Collection and Labeling Protocols For Use of Convalescent Plasma As A Treatment for COVID-19

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

4/28/2020 / Blood Tests , Coronavirus Treatment Acceleration Program (CTAP) , Coronavirus/COVID-19 , Food and Drug Administration (FDA) , Guidance Update , Healthcare , Pharmaceutical Industry , Virus Testing

FDA Provides Safety Communication Relating to Use of Antimalarial Drugs Hydroxychloroquine and Chloroquine In the Treatment of...

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

4/28/2020 / Biosimilars , Coronavirus Treatment Acceleration Program (CTAP) , Draft Guidance , FDA Approval , Food and Drug Administration (FDA) , Generic Drugs , Pharmaceutical Industry , Prescription Drugs , Resource Guide

FDA Provides Guidance on How to Request Authorization to Use Convalescent Plasma as a Treatment for COVID-19

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

4/27/2020 / Centers for Medicare & Medicaid Services (CMS) , Convalescent Plasma , Department of Health and Human Services (HHS) , Food and Drug Administration (FDA) , Investigational New Drug Application (IND) , Pharmaceutical Industry , Prescription Drugs

FDA Authorizes Synthetic Nasal Swab to Increase COVID-19 Testing

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

Guide For General Public: FDA Explains How Everyone Can “Make a Difference” During COVID-19 With Simple Infographic, Update

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

4/21/2020 / Clinical Laboratories , Consumer Information , Coronavirus Treatment Acceleration Program (CTAP) , Food and Drug Administration (FDA) , Guidance Update , Hospitals , Medical Devices , Virus Testing

FDA and NCI to Review COVID-19 Antibody Tests Marketed Under FDA Guidance Permitting Sale Without FDA Authorization

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

Head to Toe: Summary of FDA COVID-19 Guidance Relating to Gowns, Other Apparel, and Gloves

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

4/13/2020 / Coronavirus/COVID-19 , Food and Drug Administration (FDA) , Guidance Update , Masks , Medical Devices , Medical Equipment , Personal Protective Equipment , Supply Chain

FDA Announces the Creation of CTAP—Coronavirus Treatment Acceleration Program—to Assist Drug Developers and Evaluators

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

FDA Issues Guidance Documents Directed to Blood Donations as Part of COVID-19 Public Health Emergency Measures

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

4/3/2020 / Biologics , FDA Approval , Food and Drug Administration (FDA) , Guidance Update , Life Sciences , Medical Devices , Pharmaceutical Industry , Product Labels , Public Health

FDA Issues Guidance Regarding Alcohol-Based Hand Sanitizers For COVID-19 Prevention

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

4/3/2020 / Draft Guidance , Food and Drug Administration (FDA) , Health Care Providers , Manufacturers , Medical Devices , Personal Care Products

FDA Emergency Use Authorizations (“EUA”) for COVID-19: What is an EUA and What is Currently Covered?

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

FDA Eases Enforcement to Expand Remote Care of Pets and Food-Producing Animals

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

FDA Eases Enforcement to Help Make More Ventilators Available

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

False Advertising: Changing Your Business To Meet Market Needs During The COVID-19 Pandemic

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

Boss Moves in Makeup: A Look at the Future of Cosmetics

Seyfarth hosted its first “Future of Cosmetics and Personal Care Products" event in its New York office on November 12, 2019. The event brought together industry leaders and Seyfarth attorneys for a timely conversation on the...more

Innovation In Hatch-Waxman And ANDA Litigation

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

Sandoz v. Teva: Supreme Court Nixes Post-Approval Waiting Period for Biosimilars

Seyfarth Synopsis: In its first opinion relating to the Biologics Price Competition and Innovation Act of 2009 (“BPCIA”), the Supreme Court in Sandoz Inc. v. Amgen Inc. provided a win to biosimilar companies, eliminating the...more

6/15/2017 / Biologics , Biosimilars , BPCIA , Food and Drug Administration (FDA) , Intellectual Property Protection , Patent Applications , Pharmaceutical Industry , Pharmaceutical Patents , Teva v Sandoz

Jamaica Potts Szeliga

Seyfarth Shaw LLP

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