Mondaq USA: Food, Drugs, Healthcare, Life Sciences
Arnold & Porter Kaye Scholer LLP
At the end of December, a new version of Chapter 1 of Volume 2A of the Notice to Applicants was published by the Commission.
Sheppard Mullin Richter & Hampton
In a year when the Department of Justice recovers $2.5 billion from the healthcare industry in False Claim Act judgements and settlements, can there really be a silver lining?
Jones Day
FDA has been grappling with regulation of rapidly advancing digital products, including artificial intelligence.
BakerHostetler
With the government shutdown entering its third day, the Senate scheduled a procedural vote at noon today that could pave the way to end the stalemate...
Bowditch
article discusses the recent threat of stricter federal drug laws and what this could mean for the developing marijuana industry in Massachusetts.
Morgan Lewis
The uncertainty in several Medicare and Medicaid funding issues could cause confusion for patients and providers, and potentially hinder access to care.
Ropes & Gray LLP
On January 5, 2018, the Office of the National Coordinator for Health Information Technology ("ONC"), an office within the U.S. Department of Health and Human Services, released its Draft Trusted Exchange Framework, ...
Thompson Coburn LLP
A recent Illinois court decision involving medical cannabis is a perfect example of the growing chasm between federal and state regulation.
Holland & Knight
On Jan. 16, Chairman of the House Appropriations Committee Chairman Rodney Frelinghuysen (R-N.J.) introduced a continuing resolution (CR), which would fund the federal government until Feb. 16. Congress has until Jan.
McDermott Will & Emery
Business disruption is emerging as one of the most compelling corporate governance challenges for health care organizations.
Ogletree, Deakins, Nash, Smoak & Stewart
On January 4, 2018, Attorney General Jeff Sessions reversed the Department of Justice's (DOJ) position on enforcement of federal marijuana laws.
Seyfarth Shaw LLP
Welcome back to The Week in Weed, your Friday look at what's happening in the world of legalized marijuana.
Day Pitney LLP
The plaintiff had appealed from the trial court's ruling in favor of the defendant on two counts – negligence and negligent infliction of emotional distress.
McDermott Will & Emery
The US Food and Drug Administration's (FDA's) 2017 regulatory agenda was marked by inactivity in the months following the presidential inauguration.
Wilson Elser Moskowitz Edelman & Dicker LLP
The cannabis industry in California should expect to see a sharp increase in false advertising and unfair competition claims in 2018.
Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.
Pharmaceutical industry stakeholders know that drug prices, market competition, supply chain challenges, and shortages of critical drug products have been top of mind for policymakers in recent years.
BakerHostetler
The herbicide glyphosate, available in commercial form from Monsanto as "Roundup" since the early 1970s, had by 2007 become the No. 1 herbicide ...
Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.
It has been a few months since we reported on Federal Court wranglings with the Biologics Price Competition and Innovation Act, or BPCIA, which created the nation's abbreviated marketing pathway for biosimilar products
Poyner Spruill LLP
The 2018 State Medical Facilities Plan (SMFP) was approved by Governor Cooper on December 11, 2017, and has been issued effective January 1, 2018.
Reed Smith
On January 18, 2018, HHS announced it has established a new Conscience and Religious Freedom Division within the HHS Office for Civil Rights (OCR).
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.
Holland & Knight
Following a final vote in the U.S. House of Representatives on Wednesday morning, Dec. 20, 2017, Congress sent the Tax Cuts and Jobs Act (H.R. 1) to President Donald Trump's desk.
Holland & Knight
On March 27, 2017, the OIG released a 54-page guidance document regarding how to measure the effectiveness of a compliance program.
Womble Bond Dickinson
The key to any future advancement lies in better diagnostic tools.
Arnold & Porter Kaye Scholer LLP
While congressional Republicans safely hold the majority, we anticipate strong efforts to advance their legislative agenda.
Ropes & Gray LLP
The FDA also announced a Jan. 30, 2018, public workshop on the progress of the Software Precertification Pilot Program.
Archer & Greiner P.C.
New Jersey's economic recovery from the Great Recession has been among the slowest in the nation.
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 ...
Carlson, Caspers, Vandenburgh, Lindquist & Schuman, P.A.
Recently, the Federal Circuit reversed a jury decision upholding the validity of two Amgen patents directed to a large genus of antibodies that reduce LDL cholesterol.
BakerHostetler
A small health care provider such as a physician office or clinic often will contract with an IT services vendor to meet overall IT needs to operate the business.
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