Mondaq All Regions: Food, Drugs, Healthcare, Life Sciences
Clayton Utz
This article discusses how cybersecurity is an issue in health care since much of our information is being digitalised.
Sparke Helmore Lawyers
The issue provides information about legal issues and topics affecting health care providers, insurers and underwriters.
Sparke Helmore Lawyers
A number of states have seen significant developments affecting health care insurers and practitioners occur recently.
Sparke Helmore Lawyers
VMOs who treat patients on their own behalf are not considered employees, so do not have the same rights or protections.
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EFSA has launched a public consultation on a draft guidance document on the risk assessment of genetically modified organisms ("GMOs") present at low levels in food and feed material.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.
Morrison & Foerster LLP
On April 7, 2017, the 193rd Diet of Japan passed a legislation regarding clinical researches – this "Law on Clinical Research (rinsho kenkyu hou)" will come into effect within one year.
Day Pitney LLP
CareCore National LLC, a healthcare utilization management company, agreed earlier this month to pay $54 million to settle allegations that it allowed its insurance company customers to inappropriately bill the Medicare and Medicaid programs.
Reed Smith
A federal judge in Texas recently ruled that Texas law does not allow a claim for negligence per se based solely on alleged violations of the FDCA or FDA regulations.
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...
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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.
Cassels Brock
Although the United States government's attitudes toward cannabis have eased in recent years, the election of President Donald Trump has generated renewed uncertainty....
Deloitte
The pharmaceutical industry continues to face regulatory and reimbursement hurdles weighing on the research and development returns of pharmaceutical firms this year.
Norton Rose Fulbright Canada LLP
Global M&A activity in the biopharmaceutical industry skyrocketed in 2014 and 2015, eclipsing US$200 billion in deal value each year and prompting EY to declare such elevated activity...
Singh & Associates
The Uniform Code of Pharmaceuticals Marketing Practices, 2014 ("UCPMP Code") is a voluntary code issued by the Department Of Pharmaceuticals ("the Department") relating to marketing...
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.
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