Recreational cannabis availability through state-level legalization may contribute to reduced rates of opioid distribution, opioid use disorder (OUD), and overdose. As the opioid epidemic has evolved...
In House Bill 1047 — introduced on January 9, 2023, and sponsored by representative Sharlett Mena — Washington state has begun to take regulatory steps toward non-toxic cosmetics. The bill...
Global Pharma Healthcare has voluntarily recalled multiple batches of artificial tears after patients experienced severe side effects, such as vision loss and mortality. On January 31, 2023, the CDC...
The Orphan Drug Act of 1983 defines a rare disease as a medical condition that impacts less than 200,000 people in the United States. Despite the restrictive nature of this definition, the Genetic and Rare Diseases Information Center of...
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...
Fueled by deceit from pharmaceutical companies and over-prescription, the opioid epidemic has continued to impact thousands of lives. Throughout recent years, public health organizations and healthcare professionals have been working to...
On January 24, 2024, the FDA issued a new draft guidance regarding lead levels in processed baby food meant for children under two as part of its Closer to Zero initiative.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...
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...
As public health officials become increasingly concerned about potential pandemic pathogen (PPP) research, the NIH has published a draft recommendation to guide future research policies and practices....
While several different approaches are used during clinical research, traditional biomedical research involving animal testing to develop new treatments and drugs may be a strategy of the past after the FDA Modernization Act 2.0 was signed...
Like developing, launching, and marketing any product, drug development and launching is a complex, costly, and intricate process. However, unlike other markets, the pharmaceutical industry has an added layer of complexity associated with...
On December 29, 2022, President Biden signed the FDA Modernization Act 2.0 into law, allowing clinical trial leaders to use animal trial alternatives before human clinical trials. Senators Rand Paul,...
Earlier this year, the United States Environmental Protection Agency (EPA) announced plans to propose, establish, and enforce national drinking water regulations for perfluorooctanoic acid (PFOA),...
In a step towards widening access, the FDA made a regulatory change, allowing the abortion pill, mifepristone, to be distributed by retail pharmacies with a valid prescription. Mifepristone is one...
The clinical trial landscape — globally and in the United States — is one of many complexities, difficulties, implications, and guidelines. Clinical trials can provide critical information on treating chronic and acute...
Throughout the COVID-19 pandemic, the FDA has played a critical role in addressing public health concerns by encouraging practices to minimize infectious disease spread and expediting approval for...
Over the past few weeks, the pharmaceutical industry — drug development in particular — has faced a new issue regarding drug development and the animal models typically used to model...
Clinical trial diversity is a necessity for ensuring equitable access to healthcare. Clinical trial data is extrapolated and used to make regulatory decisions, including drug approval, dosages,...
The United States Food and Drug Administration (FDA) approval process is complex and involves multiple people's input, opinions, and expertise, including the FDA advisory committees. Every time a new drug is approved, a recall is...
Biosimilars have gained significant traction in healthcare for being more affordable alternatives to biological products. Despite the importance and benefits of biosimilars, many providers are hesitant...
