News and Articles
The Evolution of Benzene Litigation & Considerations for Product Manufacturers
Benzene may not be a household name, but in the last few years, this chemical compound has garnered public attention for its presence in everyday products and its potential cancer risks. Since discovered over two centuries ago, benzene has been used to manufacture plastics, dyes, adhesives, gasoline, cleaning products, and personal care products. With the…
FDA’s New Draft Guidance for Internet Misinformation about Medical Products
You may remember the internet postings during the height of the COVID pandemic touting hydroxychloroquine, a drug approved by the Food and Drug Administration (FDA) for the treatment of malaria and rheumatologic disease, as a prophylactic or even a cure-all for COVID-19. The postings, many initiated by celebrities such as Elon Musk and Dr. Oz…
Applying Occupational Exposure Banding to Antibody Drug Conjugates
Occupational Exposure Banding (OEB), also known as hazard banding, is a process used for assigning chemicals into categories based on toxicological potency and potential health hazard. OEB has been used to help organizations define and identify worker health exposures since the mid-1990s and has primarily focused on small-molecule chemicals, which make up most market pharmaceuticals….
Considerations for Conducting International Clinical Trials
As a startup life science company, you are excited by the promising laboratory results for your novel drug, but you must first test the product’s safety and efficacy through clinical trials. To expedite the process, you work with a clinical research organization to conduct trials outside the United States. All goes well until a clinical…
An Introduction to Innovator Liability: Brand-Name Responsibility for Generic Drug Failure to Warn Injuries
Innovator liability is a legal theory under which a consumer seeks to hold the brand-name manufacturer of a drug (the “innovator”) responsible for an injury that was caused by the generic version of that drug. This novel approach to injury culpability has gained modest ground in recent years, despite its departure from long-standing product liability…
Melatonin: The Benefits vs. the Risks of the Dietary Supplement
Melatonin was first identified by Aaron B. Lerner, an American physician and dermatologist at Yale University, in 1958. Dr. Lerner and his colleagues were initially investigating a cure for vitiligo, an autoimmune disorder characterized by the loss of skin pigmentation. Although the experimentation failed to find a cure for skin disorders, subsequent research revealed that…
The Risks of Employees Driving in Foreign Territories
The hazards of driving increase when you or your employees drive in unfamiliar territory. This is especially true when driving in foreign territories without knowing the driving rules and habits within the country. Being unfamiliar with local regulations, failing to adhere to them, or making incorrect assumptions increases the likelihood of accidents. Factors That Increase…
Organ Chip Technology
Life science companies seeking FDA approval must not only establish a new medicine’s efficacy but also comply with rigorous safety protocols and procedures. The process is time-consuming and costly: the financial burden associated with developing and securing market approval for a new compound is estimated at $2.5 billion and can take over a decade, with…
Gene Therapy: Challenges and Regulatory Developments
Our last gene therapy article highlighted several novel cures for rare, life-threatening illnesses using gene therapy technology. Many more treatments based on gene therapy are in the clinical trial phase. Despite the remarkable results thus far, significant challenges lie ahead. As with any new treatment modality, scientists must be cautious in their approach, carefully studying…
Staying Ahead in Life Sciences: 2023 in Review and 2024 Trends – Part 3
As part of the life science community, Berkley Life Sciences (BLS) stays current on litigation trends and regulatory developments that affect the industry. BLS presents these updates in an annual webinar with Kim Schmid, Executive Managing Partner at Bowman & Brooke. BLS is offering a series of three articles highlighting information from the webinar, such…
