Archive for March 4th, 2025

๐“๐ก๐ž ๐…๐ฎ๐ญ๐ฎ๐ซ๐ž ๐จ๐Ÿ ๐‚๐š๐ง๐ง๐š๐›๐ข๐ง๐จ๐ข๐ ๐“๐ก๐ž๐ซ๐š๐ฉ๐ฒ: ๐“๐š๐ซ๐ ๐ž๐ญ๐ž๐ ๐Œ๐ข๐ญ๐จ๐œ๐ก๐จ๐ง๐๐ซ๐ข๐š๐ฅ ๐€๐œ๐ญ๐ข๐ฏ๐š๐ญ๐ข๐จ๐ง

The future of cannabinoid therapy, particularly in the context of targeted mitochondrial activation, is an emerging and promising area of research. Cannabinoids, the active compounds found in cannabis, have been shown to interact with the endocannabinoid system (ECS) and other cellular pathways, influencing various physiological processes. Mitochondria, often referred to as the powerhouses of the [โ€ฆ]

US Prescribing Information STRATEGY for newly approved biologic therapy for leukemia

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 FDAโ€™s Physician Labeling Rule (PLR) format, which [โ€ฆ]

How can a Class I medical device manufacturer self-certify the CE mark?

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 deviceโ€™s design, manufacture, and performance, including: Device description and specifications. Intended [โ€ฆ]