On Nov. 22, 2023, the U.S. Food and Drug Administration (FDA) published a new resource for manufacturers of critical foods — defined as any infant formula or medical food — reminding manufacturers of their obligation to...more
On Oct. 23, 2023, the U.S. Food and Drug Administration (FDA) issued draft guidance in the form of questions and answers (Q&A) regarding manufacturers’ (Firms) dissemination of scientific and medical information on unapproved...more
On Dec. 6, 2023, the U.S. Food and Drug Administration (FDA) sent a warning letter to the owners of online hemp, tetrahydrocannabinol (THC) and cannabidiol (CBD) retailer Hemp-xr.com for introducing adulterated foods into...more
On Oct. 25, 2023, in light of a “significant rise in the number and severity of cyber-attacks against hospitals and health systems in the last few years,” the U.S. Department of Homeland Security Cybersecurity and...more
In late August 2023, the Department of Health and Human Services (HHS) recommended rescheduling marijuana from a Schedule I substance to a Schedule III substance under the Controlled Substances Act (CSA), signaling the...more
On Nov. 2, 2023, the Food and Drug Administration proposed revoking the regulation that authorizes the use of brominated vegetable oil (BVO) in food. BVO is a vegetable oil with added bromine that prevents the separation of...more
On October 11, 2023, the U.S. Food and Drug Administration (FDA) announced that it will create and accept nominations for a new Digital Health Advisory Committee (DHA Committee) that will counsel the FDA on various issues...more
The U.S. Department of Health and Human Services (HHS) Office of Research Integrity (ORI) released a notice of proposed rulemaking to update the 2005 Public Health Service (PHS) Policies on Research Misconduct. HHS seeks...more
On Oct. 7, 2023, Gov. Gavin Newsom signed the California Food Safety Act (CFSA) into law, making California the first state to ban the manufacture, sale, distribution or delivery of food products containing four food...more
In response to a growing number of cyberattacks in the healthcare and life sciences industries, on Sept. 27, 2023, the U.S. Food and Drug Administration (FDA) released updated guidance regarding cybersecurity safety...more