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
The FDA has updated its Medical Device Shortages List to remove Specimen Collection, Laboratory Reagents and Testing Supplies, Transport Media Device, Saline Vascular Access Flush, and Certain Ventilation-Related Products....more
On March 10, 2023, the U.S. Food and Drug Administration (FDA) issued a Notice summarizing which of the agency’s COVID-19-related guidance documents will be rescinded and which will be revised to temporarily remain in effect,...more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
On Tuesday, October 12, 2021, the US Food and Drug Administration (FDA) announced that it will withdraw the temporary policies originally issued in March 2020 for manufacturers that were not drug manufacturers at the time to...more
At the outset of the Covid-19 outbreak in this country, President Trump invoked the Defense Production Act of 1950, as amended, to help combat the virus. In March and April, he issued executive orders under the powers...more
In Tuesday's Report: European Commission proposes far-reaching pharmaceutical strategic plan, Biden names health care nominees, and warnings over Christmas COVID-19 spread....more
In Washington: On Thursday, the U.S. experienced the deadliest 24 Hours since the Coronavirus pandemic began as a record 2,777 Americans died in just 24 hours. More than 14 million Americans have now tested positive,...more
The U.S. Food and Drug Administration (FDA) recently unmasked new guidance surrounding distribution of surgical masks. As a brief recap, on April 16, 2020, the FDA issued an Emergency Use Authorization (EUA) authorizing the...more
This article was last updated on June 26, 2020. In view of COVID-19, we have compiled a list of important updates as it relates to the pandemic and its impact on Life Sciences. We will continue to update this page as new...more
As the COVID-19 pandemic has expanded exponentially, so too has the demand by hospitals and other healthcare providers for masks and other medical personal protective equipment (PPE) to protect doctors, nurses, and other...more
With the rapid and expansive spread of the COVID-19 pandemic, Alabama health care providers may face a shortage of critical supplies, including ventilators and dialysis machines, which would require difficult decisions...more
On Wednesday, April 8, 2020, Governor Tom Wolf entered an emergency order (“Order”) pursuant to Sections 7301 (f) (4) and 7313 (10) of the Emergency Management Services Code that authorizes the Pennsylvania Emergency...more
In a rapid and remarkable response to COVID-19, The Centers for Medicare & Medicaid Services (CMS) has altered a wide range of coverage and payment rules applicable to hospitals, practitioners and suppliers. In an interim...more
The Department of Justice Antitrust Division (the “Antitrust Division”) has granted its approval to a plan by a group of medical supply manufacturers to collaborate in response to the COVID-19 pandemic. ...more
The Trump Administration has imposed new restrictions on exports of personal protective equipment (PPE) pursuant to the Defense Production Act (DPA). On April 10, 2020, the US Federal Emergency Management Agency (FEMA) is...more
Yesterday, Governor Wolf signed an order to allow the administration to transfer supplies and information between medical facilities. The order mandates that private, public, and quasi-public health care providers and...more
UPDATE: The Interim Order No. 2 Respecting the Importation and Sale of Medical Devices for Use in Relation to COVID-19 was made on March 1, 2021 (see Notice here) and repeals the Interim Order Respecting the Importation and...more
On April 2, 2020, the Food and Drug Administration (FDA) issued a revised temporary enforcement policy regarding the manufacture and distribution of face masks and filtering facepiece respirators during the COVID-19 public...more
As healthcare providers continue to fight the coronavirus outbreak, many practices are suffering major disruptions due to the cancellation of elective surgeries and office visits, among other things. In an effort to lessen...more
Relaxation of antitrust rules to avoid shortages of supply. On 23 March 2020, the European Competition Network (ECN) issued a statement acknowledging that the current situation “may trigger the need for companies to cooperate...more
Canada’s COVID-19 Emergency Response Act came into force on March 25, 2020. Perhaps overlooked amongst emergency relief, health care and financial effects is Part 12 of the Act which makes changes to the Patent Act. Why...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
The Wall Street Journal’s Health Forum convened—virtually—on March 24th during an extraordinary period in global health: the novel coronavirus is threatening populations, overwhelming provider systems, and sending economies...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
As the number of COVID-19 cases in the U.S. continues to grow, the CARES Act makes a number of changes to support the ability of the health care system to respond to the crisis over the coming months. In addition, the package...more