The US Food and Drug Administration (“FDA” or “agency”) issued a draft guidance for Industry last week, entitled Distributing Scientific and Medical Publications on Risk Information for Approved Prescription Drugs and Biological Products – Recommended Practices.
The guidance represents the
The dairy industry is one of Australia’s leading agricultural industries with approximately 9.2 billion litres of milk produced last year, nearly half of which was exported overseas, particularly to the Asia Pacific region (largely in the form of dried/powdered
The FDA has also released draft guidance describing its current thinking regarding the dissemination of benefit and risk information for drugs and medical devices on social media platforms with character space limitations, including Twitter and sponsored internet advertisements. The FDA
A bipartisan group of senators has introduced legislation that would require CMS to take the financial status of a hospital’s patient population into account when deciding whether to financially penalize a hospital for excessive readmissions.
The Medicare Readmissions Reduction Program
On June 16, 2014, the Medicare Payment Advisory Commission (“MedPAC”) issued a report proposing five changes to legislation or Medicare regulations to improve the Medicare Shared Savings Program. MedPAC proposed, in the near term, the Centers for Medicare and Medicaid
On June 11, 2014, the US Department of Health and Human Services (“HHS”) issued two reports to Congress addressing Health Information Accountability and Portability Act of 1996 (“HIPAA”) compliance activities for calendar years 2011 and 2012. The first report, relating
In December 2013, the Government of Canada introduced Bill C-18, known as the Agricultural Growth Act. The proposed legislation is designed to streamline legislation in the agricultural sector, increase access to new crop varieties, enhance trade opportunities and food safety,
The Government of Canada recently published amendments to the Food and Drug Regulations, which will create new labelling requirements for mechanically tenderized beef.
Mechanically tenderized beef (MTB), a defined term under the new regulations, is uncooked, solid cut beef that
Last month, an E. Coli O157:H7 outbreak that caused 11 people to become ill in four states resulted in a recall of 1.8 million pounds of ground beef products that were produced by Wolverine Packing Company of Detroit. The ground
In May 2013, the California Senate passed a controversial bill requiring safety warning labels on “sugar-sweetened beverages.” The warnings must state that drinking these beverages “contributes to obesity, diabetes, and tooth decay.” The language of SB 1000 places much of