Podcast: President Biden's Use of the Defense Production Act - Diagnosing Health Care
Supporting Health Through Supply Chain Management
Product Launching in the Era of COVID-19 - Diagnosing Health Care Podcast
Blakes Continuity Podcast: Life Sciences: Liability and Immunity During COVID-19
K&L Gates Triage: Using Drones in Medicine
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
This week, North Carolina announced that it will begin long-range health care deliveries by drone in an effort to expand on-demand health care and improve the patient experience in the state. A distribution center will be set...more
ACI is excited to welcome you back in-person to the 14th Advanced Forum on FCPA & Anti-Corruption for the Life Sciences Industry, taking place on July 21–22, 2022 in Boston! Legal and compliance professionals from...more
Zipline, a drone operator and logistics company, plans to partner with Magellan Health’s pharmacy unit to deliver medical prescriptions to homes in Charlotte, North Carolina, this year, helping to jumpstart the era of...more
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
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
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
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
This Diagnosing Health Care episode looks at the adjustments to business operations and compliance programs that pharmaceutical and medical device companies need to consider as they launch new products during the ongoing...more
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
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
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
Amid the medicine and medical equipment shortages caused by the COVID-19 pandemic, Mexican President Andrés Manuel López Obrador stated that the supply of medicines in Mexico has been complicated, and therefore a purchase...more
As of June 16, 2020, the U.S. Patent and Trademark Office has implemented a program to prioritize the examination of trademark applications that cover goods and services that help prevent, diagnose, treat, or cure COVID-19....more
Arnall Golden Gregory LLP's Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community and highlights articles from members of AGG outside the Food and Drug practice....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
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
On April 4, 2020, the Antitrust Division of the Department of Justice issued its first Business Review Letter under the DOJ-FTC joint expedited COVID-19 competitor collaboration review procedures, blessing several medical...more
The Justice Department and the FBI have acted to focus on fraudsters who are preying on the public panic in response to the pandemic. The Justice Department has alerted US Attorneys’ Offices, and federal, state and local...more
Report on Supply Chain Compliance 3, no. 7 (April 2020) - The crippling severity the coronavirus outbreak has had on peoples’ daily lives and on the world’s economy is a direct result of a fragmented and thinly stretched...more
On March 27th, Congress passed and the President signed the Coronavirus Aid, Relief, and Economic Security Act (the CARES Act). On both the federal and state levels we have seen efforts to support social distancing in the...more
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
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
The Coronavirus Aid, Relief, and Economic Security Act (CARES Act), which was signed by the President on March 27, 2020, includes several provisions affecting group health plans, as discussed below. Health Plan Rules and...more
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