Cheese Consumers

Dec 10, 2024 | mondaq.com | Cheese Consumers |Sarah Clarke

As regular Big Molecule Watch readers know, the Biologics Price Competition and Innovation Act ("BPCIA") was signed into law as part of the Affordable Care Act on March 23, 2010, creating an abbreviated licensure pathway for "biosimilar" and "interchangeable" biological products.

Dec 10, 2024 | mondaq.com | Cheese Consumers |Steven Schnelle

The 2024 election results will create significant tailwinds for Republican legislative and regulatory priorities in US Congress, federal agencies, and state houses across the country. This On the Subject considers the outlook for pharmacy regulation under the second incoming Trump administration and a unified Republican Congress, as well as state-level pharmacy policies that may advance as Republican public policy momentum builds.

Dec 10, 2024 | mondaq.com | Cheese Consumers |Dominick DiSabatino |Audrey Mercer

Earlier this week, the U.S. Food & Drug Administration ("FDA" or the "Agency") released its long-anticipated final guidance (the "Guidance") on predetermined change control plans ("PCCPs") for devices that utilize artificial intelligence/machine learning ("AI/ML") software.

Dec 10, 2024 | mondaq.com | Cheese Consumers |Anna K. Abram |Nathan Brown |Caroline D. Kessler

On December 5, 2024, FDA unveiled the draft guidance for industry regarding accelerated approval for drugs and biologics. This guidance provides additional information regarding the development of drugs and biologics to treat serious conditions for which there is an unmet need, and for which the sponsor is seeking accelerated approval.

Dec 10, 2024 | marketscreener.com | Cheese Consumers

On November 13, 2024, Judge Mary M. Rowland of the U.S. District Court for the Northern District of Illinois issued a significant ruling in a putative nationwide class-action lawsuit against The Kraft Heinz Company and Kraft Heinz Ingredients Corp. The lawsuit alleges that the company falsely advertised its Macaroni & Cheese products as containing “no artificial preservatives” despite including synthetic preservatives such as citric acid and sodium phosphates.