Mondaq USA: Food, Drugs, Healthcare, Life Sciences
Jones Day
On January 27, 2017, the European Food Safety Authority ("EFSA") issued a positive opinion on the health claims regarding Vitamin C in infant foods as it relates to protection of DNA, proteins...
Jones Day
A citizen petition from the Union of Concerned Scientists asks FDA to amend regulations regarding health and nutrient content claims for packaged foods to include a disqualifying level for added sugar.
Jones Day
Last month, FDA issued a draft guidance in the form of questions and answers that addresses questions related to the compliance date, added sugars, and declaration of quantitative amounts of vitamins...
Day Pitney LLP
Although the Affordable Care Act (ACA) is referred to as Obamacare, it may not be long before the reference changes to Trumpcare since the President has begun to put his fingerprints on the ACA.
Ropes & Gray LLP
On January 19, 2017, the U.S. Department of Health and Human Services (HHS), together with 15 other federal Departments and Agencies, issued a final rule to revise and modernize the federal Policy for the Protection of Human Subjects (the Common Rule), the set of federal regulations governing the conduct of clinical research involving human subjects.
Sheppard Mullin Richter & Hampton
In Parts I-III of our blog series, Very Opaque to Slightly Transparent: Shedding Light on the Future of Healthcare, we considered the healthcare landscape before implementation of the ACA...
Jones Day
The guidance is intended to help industry comply with the requirements of that regulation with respect to measures that can significantly minimize or prevent the contamination of RTE food with Listeria.
Day Pitney LLP
HIPAA covered entities that suffered "small" data breaches in calendar year 2016 have until March 1, 2017 to report the breach to the U.S. Department of Health and Human Services'...
Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.
This blog is to highlight some key provisions and changes as MA and Part D plans prepare and finalize comments.
Foley & Lardner
On January 13, 2017, the U.S. Food and Drug Administration (FDA) issued a Discussion Paper on Laboratory Developed Tests (LDTs) (LDTs) (Discussion Paper).
Mayer Brown
Millions of Americans who were able to obtain health insurance as a result of the Patient Protection and Affordable Care Act are waiting to learn the extent to which Congress...
Day Pitney LLP
In a press release, Day Pitney LLP announced the availability of its updated HIPAA Self-Assessment Tool 2.0, designed to provide an easy and cost-effective way for...
Reed Smith
We have long suspected that the reason some judges are hostile to Daubert is because application of the doctrine involves so much work.
Congressional Republicans had hoped to fast-track ACA repeal by passing legislation repealing most of the law by early February.
Foley & Lardner
The Federal Office for Management and Budget has withdrawn the proposed omnibus guidance for the 340B Drug Pricing Program (previously referred to as the "Mega-Regs")....
Foley & Lardner
"A robust, sustainable blood system is a crucial component of every health care system."
Foley & Lardner
The Personalized Medicine Coalition (PMC) recently reported that for the third year in a row...
Reed Smith
The rule finalizes, with certain modifications, all of the AKS safe harbors and beneficiary inducement CMP exceptions noted in a proposed rule published on October 3, 2014.
Reed Smith
When we heard about Judge Neil Gorsuch being nominated for the United States Supreme Court, our first move was to enter his name in Westlaw along with the term "preemption."
Day Pitney LLP
The second review round, which will examine directories of an additional 64 MAOs, is currently in progress.
Most Popular Recent Articles
Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.
The Commissioner noted that it is her belief that successful cost containment must occur in the context of tackling social determinants of health.
Foley & Lardner
Here, we consider specific steps Trump could take–without or with Congressional approval.
Ford & Harrison LLP
As LGBTQ rights have taken center stage in political and social issues, FordHarrison has been following ground-breaking litigation related to LGBTQ rights and providing updates.
McDermott Will & Emery
The 21st Century Cures Act includes portions of the Helping Families in Mental Health Crisis Reform Act of 2016, which was approved by the US House of Representatives in July 2016, but not advanced by the Senate.
Hanson Bridgett LLP
In only a few short years, we have seen a dramatic transformation in the public's opinion toward medical marijuana. These days, medical marijuana is increasingly viewed as a legitimate...
Seyfarth Shaw LLP
Strong intellectual property is the cornerstone of most start-up companies, and in most cases it is the key asset utilized by companies in securing financing and investment.
Cadwalader, Wickersham & Taft LLP
On January 20, 2017, Donald J. Trump became the 45th President of the United States. Consistent with his campaign promises to act swiftly to "repeal and replace" the Patient Protection and Affordable Care Act . . .
Foley Hoag LLP
According to a report released by ArcView Market Research and New Frontier Data, Massachusetts may be home to a $1.1 billion cannabis industry by 2020.
McDermott Will & Emery
The US Food and Drug Administration (FDA) related portions of the 21st Century Cares Act, found in title III, establish a streamlined process for the exemption of certain Class I and II devices from the premarket notification requirement and allow for the establishment of revised regulatory standards for accessories to high-risk devices.
McDermott Will & Emery
The 21st Century Cures Act includes provisions affecting Medicare Advantage, drawing from the bipartisan Senate Finance Committee's Chronic Care Working Group, and the small employer health insurance market.
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