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 [โฆ]
Archive for March 4th, 2025
๐๐ก๐ ๐ ๐ฎ๐ญ๐ฎ๐ซ๐ ๐จ๐ ๐๐๐ง๐ง๐๐๐ข๐ง๐จ๐ข๐ ๐๐ก๐๐ซ๐๐ฉ๐ฒ: ๐๐๐ซ๐ ๐๐ญ๐๐ ๐๐ข๐ญ๐จ๐๐ก๐จ๐ง๐๐ซ๐ข๐๐ฅ ๐๐๐ญ๐ข๐ฏ๐๐ญ๐ข๐จ๐ง
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 FDAโs Physician Labeling Rule (PLR) format, which [โฆ]
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 deviceโs design, manufacture, and performance, including: Device description and specifications. Intended [โฆ]