News & Analysis as of

Food and Drug Administration (FDA) › Prescription Drugs › Medical Supplies

McDermott Will & Emery

FDA Gives Companies a New Way to Fight Misinformation

McDermott Will & Emery on

Misinformation shared by independent third parties presents a significant public health concern because it can lead patients and healthcare providers to forgo treatments that are safe and effective or choose treatments that...more

Alston & Bird

FDA Extends Pause on Non-mission-critical Domestic Surveillance inspections to February 4 – Medical Products Supply Chain Week in...

Alston & Bird on

In this week’s issue, OSHA withdrew its emergency temporary standard (ETS), which required a mandatory vaccination policy for large private employers with an exception for employers that adopt a policy requiring mandatory...more

Faegre Drinker Biddle & Reath LLP

Going Paperless: What Manufacturers Need to Know Before Digitizing Warnings

Faegre Drinker Biddle & Reath LLP on

By the time the COVID-19 pandemic began, society was well into the so-called “Digital Age,” relying heavily on electronic communications, apps, websites, and the like to go about daily activities. Everything from ordering...more

Womble Bond Dickinson

Emergency Use Authorization Issued for COVID-19 Antibody

Womble Bond Dickinson on

On November, 10, 2020, the US Food and Drug Administration (FDA) granted an Emergency Use Authorization (EUA) for the investigational neutralizing antibody bamlanivimab (Eli Lilly and Company, Indianapolis, IN) for the...more

Wilson Sonsini Goodrich & Rosati

FDA Declines to Review Certain EUAs, Raising Reimbursement and Liability Issues

Wilson Sonsini Goodrich & Rosati on

The Food and Drug Administration (FDA or the Agency) announced on October 7 that it will no longer review Emergency Use Authorizations (EUAs) for laboratory developed tests (LDTs). LDTs are a distinct category of in vitro...more

Mintz - Health Care Viewpoints

Final Canadian Drug Importation Rule and HHS Certification Issued Under Section 804 of the Food, Drug and Cosmetic Act

Mintz - Health Care Viewpoints on

As previously covered on this blog, in mid-2019 the U.S. Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA) jointly published the Safe Importation Action Plan, which outlined the Trump...more

Akin Gump Strauss Hauer & Feld LLP

Executive Order on Essential Medicines: A Timeline and Overview of Key Provisions

Akin Gump Strauss Hauer & Feld LLP on

On August 6, President Trump issued an Executive Order (EO) titled “Ensuring Essential Medicines, Medical Countermeasures and Critical Inputs Are Made in the United States.” The far-reaching EO seeks to ensure the domestic...more

Foley Hoag LLP

President Signs Executive Order to Ensure Essential Medical Products Are Made in the USA

Foley Hoag LLP on

President Donald Trump signed an Executive Order (EO) on Thursday, August 6, 2020 directing federal agencies to “Buy American” when purchasing “essential” drugs, medical supplies and equipment rather than purchase these...more

Seyfarth Shaw LLP

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

Seyfarth Shaw LLP on

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

Wilson Sonsini Goodrich & Rosati

FDA Issues Recommendations on COVID-19 Drug Development and Clinical Trials for Regulatory Approval

Wilson Sonsini Goodrich & Rosati on

The U.S. Food and Drug Administration (FDA) recently issued two guidance documents outlining the agency's expectations for COVID-19 drug development. The first guidance, "COVID-19 Public Health Emergency: General...more

Wilson Sonsini Goodrich & Rosati

FDA Issues Guidance on Use of 3D Printing on Medical Devices, Accessories, Components, and Parts

Wilson Sonsini Goodrich & Rosati on

On March 26, 2020, the U.S. Food and Drug Administration (FDA) issued guidance surrounding the use of 3D printing on medical devices, accessories, components, and parts during the COVID-19 pandemic....more

Seyfarth Shaw LLP

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

Seyfarth Shaw LLP on

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

BakerHostetler

FDA Emergency Use Authorizations (EUAs): Cutting Regulatory Red Tape for COVID-19

BakerHostetler on

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

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