They’re finally here! The long-awaited Safe Food for Canadians Regulations have been pre-published in the Canada Gazette I for comment, and the CFIA has officially kicked off consultation on the proposed regulations.
The proposed Regulations are made under the Safe
On December 13, 2016, President Obama signed into law the 21st Century Cures Act (the “Cures Act”). We detailed the Cures Act’s provisions affecting hospitals in a prior Health Law Pulse post and will focus on a more in-depth analysis
On January 18, 2017, two days before President Trump took office, the US Food and Drug Administration (FDA) issued two pieces of draft guidance for off-label communications. The first addresses communications with payors and formulary committees, and the second
The recent executive order issued by the Trump administration delays implementation of the final Common Rule to protect human research subjects.
With respect to all regulations that have been published but have not yet taken effect, President Trump has temporarily
On January 19, the U.S. Department of Health and Human Services (HHS) and 15 other government agencies published a final rule updating regulations governing the protection of human research subjects, which is commonly referred to as the “Common Rule.” As
Unless you have been living under a rock, you no doubt have noticed that drug price increases have resulted in a wave of public criticism, playing right into the media’s demonization of the pharmaceutical industry, and even becoming an election
Last week the US Food and Drug Administration (“FDA”) provided guidance on the Nonproprietary Naming of Biological Products. Each biologic, whether originator, related product or subsequent entry (biosimilar) will now be given a non-proprietary name comprised of a core
This week, the Centers for Medicare and Medicaid Services (CMS) published a refresh of its Open Payments dataset, which includes new data to account for the result of disputes and other data corrections since the last refresh in June 2016.
On January 17, 2017, Prime Minister Theresa May delivered her much anticipated speech on the UK Government’s plan for exiting the EU.
Continued membership of the EU’s single market and full membership of the customs union have both been explicitly
On January 17, 2017, the Centers for Medicare & Medicaid Services (“CMS”) finalized certain changes to the Medicare appeals process, with the intent to provide increased transparency and efficiency to cure the current backlog in pending appeals. According to CMS,