February 3, 2023 - Based on data and recommendations from an external review by the Reagan-Udall Foundation and the results of an internal study, FDA commissioner Robert M. Califf, MD, MACC, announced a new vision for the Human Foods Program. The concept includes plans to redesign the current prevention and response strategies.
The external and internal reviews identified multiple issues with the current...
February 1, 2023 - On January 31, 2023, Amgen announced that its product AMJEVITA, a Humira biosimilar, is now available in the United States. This new availability threatens the stake that AbbVie has held for decades with its patent on Humira. For many years, Humira was one of the country’s best-selling prescription drugs, amounting to over $135 billion in sales across the US. Although the rollout...
January 31, 2023 - On January 24, 2024, the FDA issued a new draft guidance regarding lead levels in processed baby food meant for children under two as part of its Closer to Zero initiative. The Closer to Zero initiative is focused on researching, analyzing, regulating, and consulting contaminant levels in food, with its primary goal of reducing childhood exposure to contaminants, namely, arsenic, lead,...
January 30, 2023 - On January 27, 2023, the FDA issued a press release linking its new draft recommendation for updated blood donation guidelines. These updated guidelines take a more modern and individual approach to blood donations, echoing the actions of multiple other developed nations, such as the United Kingdom and Canada.
Historically, the United States blood donation system has discriminated...