The U.S. Food and Drug Administration (“FDA”) recently issued three Warning Letters, all related to issues involving clinical trials.
All three letters were critical of the Institutional Review Boards (“IRBs”) charged with overseeing the clinical trials.
The first Warning Letter
Recent bipartisan legislation introduced into the US House of Representatives by House Budget Committee Chairman Paul Ryan (R-Wis) and Representative Ron Kind (D-Wis) entitled “Expanding the Availability of Medicare Data Act” (H.R. 4418) would expand the availability of Medicare claims
On April 22, 2014, the US Department of Health and Human Services (“HHS”) Office of Civil Rights (“OCR”) announced that it had reached settlement agreements with two organizations alleged to have violated the Health Information Portability and Accountability Act of
On April 10, 2014, Health Canada notified stakeholders that the Veterinary Drugs Directorate would be working in collaboration with the Canadian Animal Health Institute and other stakeholders, including provincial/territorial authorities, the pharmaceutical industry, veterinarians and food animal producers to address
Health Canada recently announced a new permitted use for tocopherols, a food preservative, and will now permit lipase from Mucor javanicus to be used in cheese flavouring and butter flavouring preparations.
Tocopherols had previously been approved for use as a
On March 18 and 19, 2014, the Conference Board of Canada unveiled the Canadian Food Strategy at the 3rdCanadian Food Summit held in Toronto, Canada.
It has been long recognized that change in the Canadian food system is
On April 9, 2014, Republican Mike Pompeo of Kansas and Democrat G.K. Butterfield of North Carolina introduced the “Safe and Accurate Food Labeling Act of 2014.” The new bill, H.R. 4432, seeks to regulate the labeling of bioengineered food under
On April 4, 2014, the Food and Drug Administration (“FDA”) issued a final rule adopting the interim final rule titled “Establishment, Maintenance, and Availability of Records: Amendment to Record Availability Requirements.” The final rule is adopted pursuant to the Food
On April 17th, President Obama announced that eight million people signed up for private health insurance coverage through the insurance marketplaces established by the Affordable Care Act (“ACA”) during the open enrollment period of October 1st through March 31st. This
The Department of Health and Human Services’ Office of Inspector General (“OIG”) has released a report in which it recommends that the Centers for Medicare and Medicaid Services (“CMS”) equalize payment rates for surgical procedures performed in hospital outpatient departments