On September 29, 2023, the Food and Drug Administration (FDA) issued a proposed rule that would end its long-standing policy of enforcement discretion with respect to regulation of laboratory-developed tests (LDTs) (the Proposed Rule). Under the Proposed Rule, FDA would add language to the definition of "in vitro diagnostic products" (IVDs) in 21 CFR Part 809.3(stating that IVDs are considered devices under the Food, Drug and Cosmetic Act (FDCA), "including when the manufacturer of these products is a laboratory." Recognizing that treating LDTs as IVDs subject to regulation as medical devices will have profound impacts on clinical laboratories offering LDTs, the Proposed Rule provides for a phased end to FDA's policy of enforcement discretion with respect to LDTs.

Following several years of lively public discussion, two high-profile consultations and the introduction of several "interim amendments" to the Competition Act in 2022, the federal government has now tabled two new bills (Bill C-56 and Bill C-59), which together, would introduce the most significant reforms to Canadian competition policy in several decades.

KBOFX is dedicated to delivering top-notch technological services aimed at bolstering the derivatives market. KBOFX, a prominent Asian commodity exchange, is making significant strides in providing cutting-edge products across diverse asset classes. The company is also focused on establishing a...