Pharmacy benefit managers (PBMs) have received criticism over the past couple of years for pocketing savings intended for patients. While this rhetoric is true for some PBMs, a small subset of the market advocates for PBM transparency and...
On February 2, 2023, the first of three eyedrops in the United States were recalled voluntarily after multiple reports of illness associated with the drops were reported to the CDC. Since then, two additional eye drops in the US...
On October 26, 2023, the United States Food and Drug Administration (FDA) issued a press release raising concerns about probiotics sold for preterm infants. The organization has sent letters to...
On October 19, 2023, the National Institutes of Health (NIH) announced plans to alter and simplify its grant review process, attempting to eliminate reputational bias in grant allocation. The updated...
In healthcare technology, the intersection of science and regulations is where innovation meets responsibility. Nowhere is this more evident than in the pharmaceutical industry, where drug safety is paramount. Regulatory compliance plays a...
On October 7, 2023, California Governor Gavin Newsom signed a bill prohibiting the manufacturing, sale, delivery, distribution, or carrying of food products for human consumption containing four presumably harmful chemicals: brominated...
Yesterday, on October 3, 2023, the United States Food and Drug Administration (FDA) announced an emergency use authorization (EUA) for an updated Novavax COVID-19 vaccine to protect against the...
On August 30, 2023, a leaked document revealed that the United States Department of Health and Human Services (HHS) plans to petition the Drug Enforcement Administration (DEA) to reclassify cannabis...
On July 27, 2023, the United States Food and Drug Administration (FDA) issued a draft guidance titled Clinical Considerations for Studies of Device Intended to Treat Opioid Use Disorder (OUD) as part...
Addressing the top 10 most common myths about medicinal and recreational cannabis is critical to promote informed decision-making, reduce stigma, and foster evidence-based discussions, leading to safer use and better public policies....
On June 22, 2023, the Scenic Fruit Company issued a voluntary recall on frozen pineapple and fruit blends, including frozen pineapple, due to potential contamination with Listeria monocytogenes. This...
On the first day of the 2023 World Medical Innovation Forum (WMIF), sponsored by Mass General Brigham Hospital and Bank of America, biopharmaceutical leaders convened a panel to challenge the Inflation Reduction Act’s (IRA)...
On May 16, 2023, the Foundation for the National Institutes of Health (FNIH) announced eight rare diseases to be explored by the Accelerating Medicines Partnership Bespoke Gene Therapy Consortium (AMP BGTC). As one of the newest additions...
After months of deliberation and review, the FDA has finally expanded its blood donor eligibility by adjusting its donation guidelines. Joining other developed nations, including the United Kingdom and...
On Wednesday, April 12, 2023, the United States Drug Enforcement Administration (DEA) issued a public safety alert on fentanyl mixed with xylazine. Linked to a press release by the Biden...
The United States Food and Drug Administration (FDA) has been criticized repeatedly for shortcomings and flaws in its oversight protocols. Understanding the current regulations that the FDA follows for assessing drug manufacturing...
On Friday, April 7, 2023, a federal judge in Texas ruled to reverse the approval of mifepristone, the abortion pill. The Trump-appointed judge, Mathew Kacsmaryk, was assigned to the Alliance for...
On March 28, 2023, British Columbia (BC), a Canadian Province, announced it would restrict Ozempic sales to United States citizens. The release from government officials notes that US citizens crossing...
An investigation published in JAMA Internal Medicine assessed FDA-approved drugs and regulatory decisions made in other countries. In particular, the study focused on regulation and health technology...
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...
