Mondaq USA: Food, Drugs, Healthcare, Life Sciences
Jones Day
EFSA has launched a public consultation on a draft guidance document on the risk assessment of genetically modified organisms ("GMOs") present at low levels in food and feed material.
Jones Day
On April 28, 2017, the European Commission issued Regulation 2017/752, amending Regulation 10/2011 on plastic materials and articles intended to come into contact with food.
Jones Day
On May 11, 2017, FDA announced a new updated fact sheet and a guidance related to the use of a Unique Facility Identifier that is acceptable under the Foreign Supplier Verification Program regulation.
Reed Smith
Now that Dr. Scott Gottlieb is safely installed as FDA Commissioner, we at DDLaw can end our moratorium on blogposts about First Amendment issues.
Day Pitney LLP
Cyberattacks on healthcare systems are becoming more frequent and increasingly devastating. As demonstrated by the recent crippling ransomware attacks on hospital computers
Jones Day
On April 19, 2017, FDA announced that both the United States and Australia have recognized each other's food safety systems as comparable to each other.
Jones Day
On May 1, 2017, FDA announced it was extending the compliance date for the menu labeling final rule from May 5, 2017, to May 7, 2018.
Jones Day
On May 9, 2017, the Senate confirmed Dr. Scott Gottlieb as the next FDA commissioner. With a 57-42 vote, the Senate filled the commissioner position most recently held by Dr. Robert Califf,...
Baker Sterchi Cowden & Rice LLC.
The old adage "location, location, location" applies as much for medical device preemption as it does for real estate.
McDermott Will & Emery
The Centers for Medicare and Medicaid Services recently finalized its proposed "market stabilization rule" (Final Rule). The Final Rule is largely consistent with the February 17 proposed rule (Proposed Rule).
Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.
On May 11, 2017, the Senate Health, Education, Labor and Pension (HELP) Committee voted in support of the FDA Reauthorization Act of 2017, or FDARA, now formally moving through the legislative process...
Foley & Lardner
On May 12, 2017, the Texas State Legislature passed SB 1107, a law expanding the use of telemedicine in the Lone Star State.
Holland & Knight
Due diligence is a critical part of assessing any acquisition. But where the target company is involved in providing healthcare items or services, the U.S. DOJ has given buyers yet another reason to...
Butler Snow LLP
The role of government as it pertains to economic development is not to create jobs. It is to create an environment where the private sector is encouraged to create jobs and investment.
WilmerHale
clash over access to and use of genetic sequence data (GSD) is currently brewing on several international fronts. To date, GSD has been routinely deposited in open-source databases such as GenBank of the National Center for Biotechnology Information ..
Day Pitney LLP
On May 15, the U.S. Supreme Court upheld a Kentucky nursing home's use of mandatory arbitration agreements in nursing home admissions.
Holland & Knight
The U.S. House of Representatives narrowly passed H.R. 1628, the American Health Care Act (AHCA), by a vote of 217-213 on May 4, 2017, with all Democrats and 20 Republicans opposing the bill.
Sheppard Mullin Richter & Hampton
With the publication of the proposed FY 2018 hospice wage index and payment update, CMS indicates further scrutiny and less compensation for hospices.
Holland & Knight
Today, the Senate Health, Education, Labor and Pensions Committee (HELP) passed legislation designed to provide patients more information about drugs that could be available under company...
Reed Smith
CMS has published a proposed rule to establish FY 2018 Medicare prospective payment system (PPS) rates for inpatient rehabilitation facility (IRF) services.
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Ropes & Gray LLP
This article highlights key business and legal issues related to value-based healthcare for investors considering opportunities in the healthcare industry.
Mayer Brown
On December 22, 2016, a dispute settlement panel established by the World Trade Organization (WTO) issued its report in Indonesia – Import Licensing (DS477/DS478)...
Ropes & Gray LLP
These documents represent a final attempt by the outgoing Administration to impact the agency's regulatory approach going forward.
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.
Akin Gump Strauss Hauer & Feld LLP
On December 27, 2016, the U.S. Court of Appeals for the 10th Circuit ruled 2­1 that the SEC's process for hiring administrative­-law judges violates the Appointments Clause of the U.S. Constitution.
Day Pitney LLP
An article in For the Record magazine entitled "Call In the Reinforcements" discussed what healthcare organizations must do to be prepared to respond in the event they suffer a data breach.
Womble Carlyle
Baltimore clients and guests heard from two leading healthcare authorities today on one of the most important issues facing the economy, the future of the Affordable Care Act. - See more at: http://www.wcsr.com/Insights/News/2017/May/Redmer-and-Schrader-Talk-Affordable-Care-Act-And-Maryland#sthash.OmujsxyZ.dpuf
Foley & Lardner
On May 12, 2017, the Texas State Legislature passed SB 1107, a law expanding the use of telemedicine in the Lone Star State.
Duane Morris LLP
Last week WV Governor Jim Justice (great name) signed into law a bill passed by the state legislature to permit the production and sale of medical marijuana in the state.
Sheppard Mullin Richter & Hampton
On April 28, 2017, the U.S. Court of Appeals for the D.C. Circuit upheld a February 8, 2017 decision by the U.S. District Court for the District of Columbia to block the $54 billion acquisition...
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