On November 24, 2015, the Centers for Medicare and Medicaid Services (CMS) issued a final rule implementing the Comprehensive Care for Joint Replacement (CJR) payment model. Under the CJR model, 67 acute care hospitals located in randomly selected metropolitan areas
Commonwealth issues new imported food controls
Australian Agriculture Minister, Barnaby Joyce, has introduced new orders designed to complete the Government’s changes to the Imported Food Control Regulations (Regulations) in respect of recognised foreign government certification.
In March 2015, the Government amended the Regulations to
FDA finalizes FSMA Foreign Supplier verification programs rule
On November 16, 2015, the Food and Drug Administration (“FDA”) finalized the Foreign Supplier Verification Programs rule (“FSVP”) for importers of food for humans and animals under the Food Safety Modernization Act (“FSMA”).
The final rule lays out risk-based requirements
So-called hangover cure beverage now subject to FDA regulation as a “drug”
The manufacturer of a self-proclaimed “anti-hangover” beverage recently received a Warning Letter from the U.S. Food and Drug Administration (FDA), dated September 17 and posted on the FDA’s website earlier this week. The drink, called Life Support, claims to “prevent
FDA issues accredited third-party certification rule
On November 13, 2015, the US Food and Drug Administration (FDA) issued a final rule establishing a voluntary program for the accreditation of third-party certification bodies to conduct food safety audits and to certify that foreign food facilities and the
Genetically modified salmon approved as safe for consumption
On November 19th, the FDA approved genetically engineered salmon as safe for humans and animals to consume, making it the first genetically modified animal to receive such approval. The decision is a historic one, as the FDA is
Judge in diabetes drug MDL tosses 750 cases under preemption defense
A California MDL judge overseeing claims that four Type 2 diabetes drugs increased the risk of pancreatic cancer has dismissed at least 750 lawsuits under a rarely used analysis of the federal preemption doctrine. In re Incretin-Based Therapies Products Liability
FDA advocates for new regulatory framework for in vitro clinical tests at November 17 Hearing before the Committee on Energy and Commerce
On November 17, 2015, the Committee on Energy and Commerce, Subcommittee on Health, held a hearing focusing on draft proposed legislation supporting a new regulatory framework for in vitro clinical tests that would comprise a new category under the Federal
HHS proposes rule to regulate Independent Living Services and Centers for Independent Living
The Administration for Community Living (ACL), a division of the Department of Health and Human Services, promulgated a proposed rule on November 16 taking charge of the Independent Living Services (ILS) and Centers for Independent Living (CILS or Centers) programs.
The FDA issues Produce Safety Final Rule
On November 13, 2015, the US Food and Drug Administration (FDA) issued a final rule addressing the Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption, a rule first proposed by the FDA in January 2013.