Despite today’s challenging fiscal climate, the U.S. Food and Drug Administration released a draft of its ambitious strategic goals and objectives for keeping patients and consumers safe, the “Food and Drug Administration Strategic Priorities 2014-2018,” which will be used to
No sanctions on direct-to-patient product-sales program
The Office of Inspector General (OIG) has concluded that it would not impose sanctions on a pharmaceutical manufacturer for operating a direct-to-patient product-sales program that allows certain customers to purchase a manufacturer’s brand-name product for a fixed cash price from
A two-pronged prescription: The FDA releases new social media guidelines
The U.S. FDA released two new sets of guidance regarding the use of social media to disseminate information about prescription drugs and medical devices. This guidance supplements years of FDA warning letters and untitled letters sent to manufacturers, packers or
“No-wash” poultry labelling: coming soon to a chicken near you?
According to Health Canada, more than 4 million Canadians suffer from food poisoning every year. While most cases are minor with no permanent ill effects, serous outbreaks can lead to recalls, as well as the spectre of civil liability
Canadian Nutrition Facts information: clearer and sweeter than ever?
On July 14, 2014, Canada’s Minister of Health, Rona Ambrose, as part of Canada’s Food Labelling Modernization Initiative, announced a consultation process for proposed changes to the requirements surrounding the nutrition information displayed on Canadian food labels. The consultations involve
FDA Warning Letter update
It is FDA’s practice to issue Warning Letters in order to provide individuals and companies an opportunity to take voluntary and prompt corrective action before it initiates an enforcement action. The agency’s position is that it issues Warning Letters only
Legislation would provide FSIS with increased authority
On June 25th, Representatives Rosa DeLauro (D-CT) and Louise Slaughter (D-NY) introduced a bill in the House of Representatives that would amend the Federal Meat Inspection Act, the Poultry Products Inspection Act, and the Egg Products Inspection Act. In particular,
FDA releases first biannual progress report on its strategy to promote judicious antimicrobials in food-producing animals
On June 30, 2014, the Food and Drug Administration (“FDA”) released its first biannual progress report on its strategy to reduce antimicrobial resistance through the judicious use of antimicrobials, including in food-producing animals.
In December of 2013, FDA had imposed
Criminal trial of Peanut Corporation of America executives scheduled for July 28, 2014
The federal criminal trial of Peanut Corporation of America executives allegedly responsible for a deadly salmonella outbreak is scheduled to begin in Georgia on July 28, 2014.
Last year, Peanut Corporation of America executives Stewart Parnell, Michael Parnell, and Mary
Changes proposed to Sunshine Act reporting would remove CME exclusion, may broaden availability of “indirect-payments” exclusion
On Friday, July 11, the Centers for Medicare & Medicaid Services (CMS) proposed potentially significant revisions to the federal Sunshine Act rules. Among other changes, CMS suggested eliminating the rule section that explicitly excludes certain continuing medical education (CME) speaker