Mondaq USA: Food, Drugs, Healthcare, Life Sciences
Singh & Associates
On January 11, 2018, the US-FDA announced that it is requiring safety labeling changes to limit the use of prescription opioid cough and cold medicines containing codeine or hydrocodone in children younger than 18 years of age ...
Singh & Associates
The United States Food and Drug Administration (USFDA) on January 18, 2018, released a draft guidance "Public Warning and Notification of Recalls Under 21 CFR Part 7, Subpart C" explaining new policy steps for ...
Seyfarth Shaw LLP
Changes to both federal and Texas law which occurred in 2017 will broaden the circumstances under which physicians can make use of telemedicine services.
Dickinson Wright PLLC
Our nation is beset by an opioid epidemic that is colossal in scope and devastating in effect. The human and economic toll of this plague is stunning. Every day, more than 100 Americans die from an opioid overdose.
Sheppard Mullin Richter & Hampton
On January 25, 2018, Associate Attorney General Rachel Brand issued a memorandum on behalf of the U.S. Department of Justice (DOJ) (the "Brand Memo") ...
Haug Partners
Antitrust Associate Amanda Hamilton published an article in FDLI's Update Magazine for the January-February 2018 Issue entitled "Navigating an FTC Drug Pricing Investigation
Thompson Coburn LLP
The final rule governing changes to the Substance Abuse and Mental Health Services Administration (SAMHSA) regulations became effective February 2, 2018.
Day Pitney LLP
While manufacturers are generally responsible for initiating medical device recalls, providers are usually best positioned to identify and notify affected patients and quarantine identified devices.
Reed Smith
When a drug or device case goes to trial, who is the most important witness? Let's straightaway eliminate the plaintiff as a possible answer to that question.
Holland & Knight
After the issuance of various extensions, the Zika virus state of emergency declared by Florida Gov. Rick Scott has terminated after the governor did not renew the Executive Order.
Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.
As we predicted in our year-end post on civil and criminal enforcement trends, 2018 is already off to strong start in opioid-related enforcement against individual providers and associated practices.
Foley & Lardner
The Personalized Medicine Coalition (PMC) recently published its "Personalized Medicine at FDA: 2017 Progress Report" (Report) that highlights drug approval developments and milestones achieved in 2017.
Foley Hoag LLP
The past couple of weeks have involved a flurry of healthcare-related developments, including on the Medicaid drug pricing front.
Foley & Lardner
Hospital-based telemedicine services continue to rapidly expand across the country, allowing providers to deliver care to rural areas and better allocate the staffing and availability of specialist physicians such as neurologists and emergency medicine.
McDermott Will & Emery
Penrose v. Buffalo Trace Distillery, E.D. Mo. 4:17-cv-00294-HEA, involves the labeling of Old Charter bourbon.
Seyfarth Shaw LLP
Welcome back to The Week in Weed, your Friday look at what's happening in the world of legalized marijuana.
McDermott Will & Emery
In a two-page memorandum, the US Department of Justice (DOJ) announced a broad policy statement prohibiting the use of agency guidance documents as the basis for proving legal violations in civil ...
Day Pitney LLP
A February 13 article in Bloomberg BNA's Health IT Law & Industry Report and other publications, "Trump Budget Takes an Ax to Health-Care IT Agency," ...
Archer & Greiner P.C.
We are sending this alert to direct your attention to the fact that a little known regulatory deadline is rapidly approaching for all New Jersey licensed health care facilities.
Sheppard Mullin Richter & Hampton
On Friday, February 9, 2018, President Trump signed the Bipartisan Budget Act of 2018, a two-year budget which, in significant part, made substantial revisions to Medicare, including the Medicare Advantage (MA) program.
Most Popular Recent Articles
Morgan Lewis
Amgen paints a different picture as to the bad actor during the parties' negotiations pursuant to the Biologics Price Competition and Innovation Act.
Lowndes, Drosdick, Doster, Kantor & Reed, P.A.
Notwithstanding what we consider a well-reasoned and proper ruling by an Administrative Law Judge against Governor Scott's emergency rule on generators and fuel, cautious senior living facility...
BakerHostetler
White House Eyes Panel on Drug Prices While Senators Call for Transparency...
Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.
Massachusetts lawmakers have returned from summer recess and are preparing to tackle a robust legislative agenda this fall.
Seyfarth Shaw LLP
In a recent article, senior officials with the Department of Justice's Office of the United States Trustee (the "UST"), the federal government's watchdog of the bankruptcy system ...
Singh & Associates
On December 1, 2017, the United States Food and Drug Administration (USFDA) gave approval to Ogivri (trastuzumab-dkst) ...
Miller Friel
Opioid insurance coverage is now one of the most important issues faced by the pharmaceutical industry, which is now in the cross-hairs of plaintiffs lawyers.
Day Pitney LLP
Beginning January 16, the amount of compensation that a New Jersey healthcare provider can accept from pharmaceutical manufacturers for "bona fide services," ...
Ogletree, Deakins, Nash, Smoak & Stewart
News accounts report that thousands of Californians celebrated the first day of 2018 by exercising their new right to legally purchase marijuana for recreational use.
Klein Moynihan Turco LLP
Last week, a number of vape shops represented by the Pacific Legal Foundation ("PLF") filed federal lawsuits around the country challenging e-cigarette marketing restrictions contained...
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