Mondaq USA: Food, Drugs, Healthcare, Life Sciences
Duane Morris LLP
On July 9, 2019, the U.S. Food and Drug Administration (FDA) released a final guidance on changes to approved Risk Evaluation and Mitigation Strategies (REMS).
Hogan Lovells
The U.S. Food and Drug Administration (FDA) recently issued the first Warning Letter addressing violations of the Foreign Supplier Verification Program (FSVP) rule, one of the seven major FDA
Seyfarth Shaw LLP
In a time where marijuana legalization is rapidly expanding, all employers should reassess their workplace drug testing policies to be sure they are in compliance with existing and soon to be effective state and local laws.
Reed Smith
Issued in January 2018, the so-called Brand Memo reminded Department of Justice (DOJ) attorneys that "[g]uidance documents cannot create binding requirements that do not already exist by statute or regulation."
Reed Smith
Today's post looks at a case where a defendant was in the wrong place. You might say the same thing about us. As you read this, we are on summer holiday.
Lewis, Thomason, King, Krieg & Waldrop, P.C
Who is treating you when you go to a Tennessee emergency room? Is your doctor an employee of the hospital or is he an employee of a staffing service that is an independent contractor
Thompson Coburn LLP
On August 9, 2019, Illinois Governor J.B. Pritzker signed into law Illinois Senate Bill 2023, which amends and makes permanent the State's
BakerHostetler
FDA Remarks at National Industrial Hemp Council 2019 Hemp Business Summit – The Principal Associate Commissioner for Policy
STA Law Firm
Gene editing is a technology and development that has arisen primarily in recent years. It is a topic that is still to this day surrounded by controversy and many ethical question and concerns.
Reed Smith
The Centers for Medicare & Medicaid Services (CMS) has published its final rule to update the Medicare inpatient rehabilitation facility (IRF) prospective payment system (PPS) for fiscal year
Reed Smith
The Centers for Medicare & Medicaid Services (CMS) will increase Medicare inpatient psychiatric facility (IPF) prospective payment system (PPS) payments by 1.5%, or $65
Holland & Knight
Of course, this makes no sense because it would render the PBA meaningless.
Reed Smith
While the latest federal budget agreement signed into law earlier this month provides a reprieve from statutory budget caps for certain defense and domestic programs, it extends Medicare sequestration cuts for an...
McDermott Will & Emery
On August 12, 2019, the Alcohol and Tobacco Tax and Trade Bureau (TTB) published its updated Formula and Process for Nonbeverage Product, TTB Form 5154.1.
Reed Smith
What follows is the second part of our extensive 50-state of cases precluding plaintiffs from proceeding with claims in the absence of admissible expert support. Part One was last week.
Reed Smith
The Centers for Medicare & Medicaid Services (CMS) has proposed updating Medicare end-stage renal disease (ESRD) prospective payment system (PPS) rates by 1.7% for calendar year 2020
Reed Smith
The Centers for Medicare & Medicaid Services (CMS) is planning a potentially-significant overhaul of Medicare pricing rules for new items of durable medical equipment (DME), prosthetics, orthotics and supplies (DMEPOS)
BakerHostetler
Most recently, the states of Mississippi and Arkansas have been sued by plant-based food producers over these laws.
BakerHostetler
FDA Releases Q&A on Nonclinical Toxicology Studies – The FDA published a draft guidance titled "Pathology Peer Review in Nonclinical Toxicology Studies: Questions and Answers."
Thompson Coburn LLP
As if wading through the NAICS codes to complete the Hart-Scott-Rodino form's Item 5 wasn't exciting enough already, this fall HSR filers can anticipate an added adrenaline surge when reporting annual revenues under Item 5.
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Jones Day
Data privacy- and security-related class actions appear to be on the rise, and effectively defending them requires the right mix of substantive and procedural knowledge.
Jones Day
On the heels of the European Union's General Data Protection law, which went into effect in May 2018
Butler Snow LLP
Many state legislatures across the country have enacted statutory measures to limit the amount of compensatory and/or punitive damages recoverable ...
Holland & Knight
The Centers for Medicare & Medicaid Services (CMS) on Nov. 1, 2018, published the Calendar Year (CY) 2019 Final Rule for the Medicare Physician Fee Schedule (PFS).
Dentons
FDA expedites its efforts to develop rules for CBD and plans to report on its progress by late summer/early fall.
Squire Patton Boggs LLP
On June 25, 2019, Illinois governor J.B. Pritzker signed HB 1438, the Illinois Cannabis Regulation and Taxation Act ("CRTA"), which, as of January 1, 2020, legalizes recreational use and possession of marijuana by adults...
Arnold & Porter
On May 26, 2017, the new European Medical Devices Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR) entered into force.
Dentons
Bills were introduced in Congress to allow for interstate cannabis commerce and to end the practice of deporting and denying citizenship to immigrants engaged in cannabis-related activities.
Wolf, Greenfield & Sacks, P.C.
Today, companies are developing AI systems to meaningfully analyze the deluge of biomedical data.
Reed Smith
We recently blogged about the final chapter (at the district court level, anyway) of the big defense win in the Mirena MDL.
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