Mondaq USA: Food, Drugs, Healthcare, Life Sciences
Jones Day
On November 16, 2015, Guido Rasi assumed the position of executive director of the EMA. He was appointed following his statement to the European Parliament's Committee on Environment, Public Health and Food Safety last month.
Reed Smith
A new OIG report reviews Medicare Part B spending on drugs purchased by eligible health care providers through the 340B drug discount program.
Reed Smith
The Obama Administration has released its latest regulatory agenda, which lists major pending or planned regulatory actions and the anticipated timing of rulemaking activity.
Reed Smith
CMS is holding a town hall meeting on February 16, 2016 to discuss fiscal year (FY) 2017 applications for add-on payments for new medical services and technologies under the Medicare IPPS.
Reed Smith
CMS has announced that the Advisory Panel on Hospital Outpatient Payment (HOP Panel) will hold its next meeting on March 14-15, 2016.
Jones Day
Guidance for Industry and Food and Drug Administration Staff: Class II Special Controls Automated Blood Cell Separator Device Operating by Centrifugal or Filtration Separation Principle...
Jones Day
Guidance for Industry: Formal Meetings Between the FDA and Biosimilar Biological Product Sponsors or Applicants, November 18, 2015, Federal Register.
McDermott Will & Emery
The guidance contains specific recommendations on the use of the term GMO for genetically modified organism.
Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.
Those wishing to comment on revisions to the Federal Policy for Protection of Human Subjects could add a 30-day comment period extension to the things they were grateful for at this year's Thanksgiving dinner.
Reed Smith
On November 18, 2015, the House Energy and Commerce Committee approved several public health policy bills.
Reed Smith
President Obama has signed into law S 799, the Protecting Our Infants Act of 2015, which is intended to combat the rise of prenatal opioid abuse and neonatal abstinence syndrome (NAS).
Hanson Bridgett LLP
On October 5, 2015, Governor Brown signed the controversial End of Life Option Act, making California the fourth state to enact legislation allowing terminally ill individuals to take life-ending drugs.
Cadwalader, Wickersham & Taft LLP
The ultimate fate of Executive Order 38, together with the promulgated regulations, still remains uncertain.
Day Pitney LLP
A new proposed bill in New Jersey would require healthcare providers to disclose to patients in advance whether their services are covered in-network by the patient's health insurance plan.
Jones Day
In the October 27, 2015, Federal Register, FDA issued a final order classifying an autosomal recessive carrier screening gene mutation detection system into class II (special controls).
Jones Day
In the November 2, 2015, Federal Register, FDA issued a final order classifying a gastrointestinal microorganism multiplex nucleic acid-based assay into class II (special controls).
Wilson Elser Moskowitz Edelman & Dicker LLP
In Rojas v. Cigna Health and Life Ins. Co., 793 F.3d 253, 258 (2d Cir. 2015), the Second Circuit joined several other circuits in holding that "healthcare providers are not 'beneficiaries' of an ERISA...
Jones Day
In the November 17, 2015, Federal Register, FDA issued a reproposal of a proposed rule to classify IVD devices for Bacillus species (spp.) detection into class II (special controls)...
Jones Day
In the November 17, 2015, Federal Register, FDA issued a priority review voucher to the sponsor of a rare pediatric disease product application for Strensiq (asfotase alfa), manufactured by Alexion Pharmaceuticals, Inc.
Jones Day
In the November 18, 2015, Federal Register, FDA published a list of premarket approval applications ("PMAs") that have been approved between July 1, 2015, and September 30, 2015.
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Thompson Coburn LLP
The Oregon Attorney General's Office hit General Nutrition Centers (GNC) with a lawsuit last week alleging that the company knowingly sold supplements that contained FDA-banned ingredients.
Thompson Coburn LLP
After being the first state to legalize medical marijuana almost 20 years ago, California is implementing regulations across the industry.
Holland & Knight
A grand jury in the U.S. District Court for the District of Massachusetts has returned an indictment against W. Carl Reichel, a former president of Warner Chilcott PLC's pharmaceuticals division, ..
Foley & Lardner
Telemedicine is a key component in the health care industry shift to value-based care as a way to generate additional revenue, cut costs and enhance patient satisfaction.
Reed Smith
Today the Centers for Medicare & Medicaid Services (CMS) published the final rule to update the Medicare physician fee schedule (MPFS) for calendar year (CY) 2016.
Fisher & Phillips LLP
One of the new Affordable Care Act (ACA) requirements imposed on employers is the obligation to report employee group health plan coverage information to the IRS and employees on Forms 1094-C and 1095-C.
Frankfurt Kurnit Klein & Selz
Here's some news for companies that have to comply with the privacy provisions of the Health Insurance Portability and Accountability Act ("HIPAA").
Holland & Knight
Class action litigation is on the rise in the food industry. The jurisdictions that still see the majority of federal class action filings are California, New York, Illinois and Florida.
McDermott Will & Emery
On October 28, 2015, the U.S. House of Representatives approved legislation that, if enacted, would, among other things, substantially alter how and how much Medicare pays for outpatient services furnished by hospitals.
Patterson Belknap Webb & Tyler LLP
After the FDA approved the first U.S. biosimilar, Sandoz's Zarxio (filgrastim-sndz), earlier this year, many predicted that the floodgates would open for biosimilar products.
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