For a newly approved biologic therapy for leukemia, the wording of the U.S. Prescribing Information (USPI) is critical to ensure clarity, accuracy, and compliance with FDA regulations while effectively communicating essential information to healthcare providers. Here are key strategies for the biologic manufacturer: 1. Adhere to FDA Format and Content Requirements: Follow the FDA’s Physician Labeling Rule (PLR) format, which […]

For a medical device manufacturer to self-certify EU conformity for a Class I cannabis oil vaporizer, the following documents must be prepared and made available to demonstrate compliance with the Medical Devices Regulation (MDR) 2017/745: Technical Documentation: A comprehensive set of documents that demonstrate the device’s design, manufacture, and performance, including: Device description and specifications. Intended […]

A 510(k) submission to the U.S. Food and Drug Administration (FDA) is a premarket notification required for demonstrating that a medical device is substantially equivalent to a legally marketed predicate device. The submission must be well-organized and comprehensive. Below is a typical Table of Contents (ToC) structure for a 510(k) application, including sections and subsections: 1. Cover Letter Applicant […]

The best single episode of any podcast (subscribe to 70) that I have heard this year. The episode is so good, I will probably repost this message a couple times in 2025. “In 1962, President John F. Kennedy said, “Those who make peaceful revolution impossible will make violent revolution inevitable.” It was a recognition of a […]

Parkinson’s Disease Parkinson’s disease (PD) is the second most common neurodegenerative disease after Alzheimer’s disease. Performed market assessment for some of the latest (2024) treatments for PD. (1) Produodopa—a new treatment approved by NICE for people with PD who experience movement-related symptoms. It’s delivered continuously by a small pump that’s inserted under the skin. (2) […]

https://biomedres.us/pdfs/BJSTR.MS.ID.009118.pdf  https://www.researchgate.net/publication/383861594_An_Independent_Review_of_Camrelizumab-Rivoceranib_Combination_Therapy_for_the_Treatment_of_Hepatocellular_Carcinoma_and_Rivoceranib_for_Gastric_Cancer/ Abstract: The CARES-310 clinical trial compared the safety and efficacy of camrelizumab, an anti-PD-1 antibody, combined with rivoceranib, a vascular endothelial growth factor receptor 2 (VEGFR2)-targeted tyrosine kinase inhibitor (TKI), versus the obsolete standard of care sorafenib as first-line (1L) treatment for unresectable hepatocellular carcinoma (uHCC). In this independent analysis of the CARES-310 […]

In the obesity landscape, glucagoon-like peptide-1 (GLP-1) agonists dominate the weight loss market. Amylin agonists work differently from GLP-1s but may be able to induce similar weight loss with fewer adverse events. My client wanted to understand the molecular differences between various amylin assets and their hypothetical impacts on the efficacy / adverse event profile. […]

Pictures shot by Heather Cox Richardson while kayaking.