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Buchanan Ingersoll & Rooney PC
COVID-19 is disrupting society and healthcare in numerous profound ways. One way that is currently being overlooked, though, is the disruption to ongoing or planned clinical trials.
Wilson Elser Moskowitz Edelman & Dicker LLP
In response to a recent directive from Congress, the U.S. Food and Drug Administration (FDA) has released a report that describes
Sheppard Mullin Richter & Hampton
The U.S. Food and Drug Administration (FDA) issued two Emergency Use Authorizations (EUA) for commercially distributed COVID-19 diagnostic tests at the end of last week.
Reed Smith
Now comes the pathos of social distance.
McDermott Will & Emery
On Friday, March 13, 2019, in the wake of growing concerns and related mass cancellations of large events all across the United States, the federal Alcohol and Tobacco Tax
Arnold & Porter
Given the ongoing public health crisis, companies working to provide products and services to support the US response to the COVID-19 pandemic should be aware ...
Duane Morris LLP
Consumers want answers from FDA on how it plans to regulate the multibillion dollar market for CBD-related products—and they're not alone.
Shipman & Goodwin LLP
In response to the ongoing developments regarding the COVID-19 outbreak, the U.S. Drug Enforcement Administration (the "DEA") has temporarily permitted providers to prescribe controlled substances via telemedicine.
Shipman & Goodwin LLP
Here is a current list of "essential services and goods" under Executive Order 7H. We will update as more guidance becomes available:
Reed Smith
The Centers for Medicare and Medicaid Services (CMS) has announced a new voluntary Part D Senior Savings Model (the Model) intended to reduce Medicare beneficiary cost
Reed Smith
Like most of you, and like our co-bloggers (from whom you will hear similar laments this week) we are in the midst of "social distancing."
Hogan Lovells
On 18 March 2020, in addition to a series of responses to combat the COVID-19 pandemic, the U.S. Food and Drug Administration (FDA) announced that it is temporarily postponing all domestic routine surveillance facility inspections.
Reed Smith
The advent of generic preemption in PLIVA, Inc. v. Mensing, 564 U.S. 604 (2011) ("Mensing"), and Mutual Pharmaceutical Co. v. Bartlett, 570 U.S. 472 (2013) ("Bartlett"), left plaintiffs who took generic drugs scrambling to invent bizarre, novel, and in some cases dangerous supposed causes of action.
Sheppard Mullin Richter & Hampton
On Thursday, March 12, 2020, the California Department of Managed Health Care (the "Department") released a guidance letter (the "Letter") to all health care service plans regarding the coronavirus (COVID-19) pandemic.
Seyfarth Shaw LLP
As concerns about community spread of the 2019 Novel Coronavirus disease ("COVID-19") mount, New Jersey has taken measures to ensure social distancing and help "flatten the curve" and slow the spread of COVID-19.
Reed Smith
The recent spate of gadolinium cases brought by patients with normal kidney function are looking like fertile ground for federal preemption, and we are not saying that just because we like the results.
Sheppard Mullin Richter & Hampton
The Centers for Medicare and Medicaid Services (CMS) and the Office of Personnel Management (OPM) issued guidance to their contracting carriers on various issues surrounding the novel ...
Butler Snow LLP
Earlier this week, we discussed current trends and future implications of COVID-19 on businesses operating in the products arena, noting the most direct impact so far on the pharmaceutical and medical device spaces.
Sheppard Mullin Richter & Hampton
U.S. Food and Drug Administration (FDA) Commissioner Stephen M. Hahn, M.D., announced that FDA is postponing foreign inspections through April 2020 in response to the COVID-19 outbreak
Holland & Knight
The Centers for Medicare and Medicaid Services (CMS) continues to offer guidance related to the coronavirus (COVID-19) outbreak.
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