Mondaq USA: Food, Drugs, Healthcare, Life Sciences
Jones Day
On May 28 and 29, 2018, the Commission published two studies aimed at examining the economic and legal impacts of the EU's regime on SPCs in particular, as well as on pharmaceutical incentives and rewards in general.
Ropes & Gray LLP
The European General Data Protection Regulation, which took effect on May 25, 2018, requires that all processing of personal data subject to the GDPR must have a legal basis under the GDPR's Article 6.
Holland & Knight
On June 12, 2018, the U.S. Food and Drug Administration (FDA) released draft guidance entitled "Drug and Device Manufacturer Communications With Payors, Formulary Committees ...
Mayer Brown
In the final days of his presidency, Barack Obama signed the 21st Century Cures Act, a sweeping medical innovation bill intended to boost funding for medical research, simplify the approval process...
Carlton Fields
This is the first episode of what will be a bi-monthly podcast during which I will discuss trends and current events in the health care industry.
Sheppard Mullin Richter & Hampton
On February 26, 2018, twenty states (the "Plaintiffs") jointly filed a lawsuit[1] in the U.S. District Court for the Northern District of Texas requesting that the court strike down ...
Reed Smith
On this date 46 years ago, President Nixon and his aides had a conversation about the Watergate break-in and cover-up.
Ropes & Gray LLP
In January 2017, the federal departments and agencies that follow the Federal Policy for the Protection of Human Subjects, typically referred to as the Common Rule ...
McDermott Will & Emery
A proactive strategy for managing regulatory risk will help to avoid creating or discovering impediments that can disrupt or fatally derail the investment and at the same time enhance the digital health innovation's potential.
Seyfarth Shaw LLP
Welcome back to The Week in Weed, your Friday look at what's happening in the world of legalized marijuana.
Reed Smith
You're likely all familiar with the phrase, "don't look a gift horse in the mouth."
Arnold & Porter
The advertising of medicinal products in the UK is controlled by a combination of legislation and codes of practice.
Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.
Earlier this week, I moderated a panel discussion at an event hosted by the New York chapter of the Health Information and Management Systems Society (HIMSS).
Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.
On Thursday June 14, 2018, the US Court of Appeals for the Federal Circuit ruled against two health plans seeking risk corridors payments from the federal government.
Day Pitney LLP
Any attempt by the provider or facility to collect more than the co-payment, deductible or co-insurance is prohibited.
Reed Smith
You'll have to excuse us a bit today.
Arnold & Porter
While the Clinical Trials Regulation (EU No. 536/2014) (the Regulation) was adopted in April 2014, the Regulation does not come into operation until 6 months ...
Ropes & Gray LLP
The changes to the guidance documents are extensive, but generally provide additional flexibility for manufacturers to convey certain types of product information.
Morgan Lewis
The documents issued by the US Food and Drug Administration on shared system risk evaluation and mitigation strategies signal the FDA's willingness to grant waivers from the shared program requirement, but that may complicate matters for the companies trying to negotiate them and the healthcare providers trying to navigate them.
Reed Smith
The MDL court in the Testosterone Replacement Therapy litigation recently entered summary judgment in favor of a non-US manufacturer that did not distribute in the US, along with its US subsidiary.
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Foley Hoag LLP
Earlier this year, the Department of Justice, Civil Division, issued two policy memos that will directly affect its civil enforcement priorities, particularly with regard to healthcare and life sciences companies.
Shearman & Sterling LLP
This past year has seen renewed challenges to reverse payment settlement agreements in the pharmaceutical industry.
Singh & Associates
An experimental drug derived from cannabis is well poised to become the first of its kind drug to win approval from the United States Food and Drug Administration (USFDA).
Morrison Mahoney LLP
When the internet started to gain widespread commercial use in the early 1990s, few could have predicted the massive shift that it would have on our lives. Its power has been harnessed...
Wilson Elser Moskowitz Edelman & Dicker LLP
Also named is SC Laboratories Inc., the logo of which appears on the vape cartigage product's packaging.
McDermott Will & Emery
On April 30, 2018, the U.S. District Court for the District of Massachusetts dismissed the last remaining state FCA claims against long-term care pharmacy provider PharMerica, Inc. on the grounds that neither relator...
Holland & Knight
On April 30, 2018, the U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) issued a favorable Advisory Opinion No. 18-02 regarding the provision of sample ostomy products...
Seyfarth Shaw LLP
California's AB 2069, a bill to require employers to accommodate medical cannabis users, recently failed to advance past committee.
Davis & Gilbert
The U.S. Food and Drug Administration (FDA) and class action bar are continuing to pursue enforcement and litigation against food and dietary supplement manufacturers who make drug claims ...
Akin Gump Strauss Hauer & Feld LLP
Washington saw a flurry of bipartisan activity over the last few weeks. Most notably, Republican and Democratic negotiators reached a long-awaited deal on sequestration budget caps.
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