Newsletter - December 10, 2020
Gut Microbiome Related to Depression: Regulatory Implications
Gut microbiome has been suggested to be linked to several diseases seemingly unrelated to the digestive system with the scientific literature rife with anecdotes and poorly designed studies. A report published this week provides a novel approach to establish microbiome-disease relationship that, in turn, could provide a scientific strategy....Read More
It’s All in the Name: FDA Releases Two Guidances for Proprietary Names
Proprietary names of drugs and biologics are valuable for building the brand recognition and medication preferences of doctors and patients alike. To emphasize the importance of appropriate proprietary names, also called Brand names, of both prescription and non-prescription drugs and biologics, FDA this week released two Guidance Documents....Read More
Gut Microbiome Related to Depression: Regulatory Implications
Gut microbiome has been suggested to be linked to several diseases seemingly unrelated to the digestive system with the scientific literature rife with anecdotes and poorly designed studies. A report published this week provides a novel approach to establish microbiome-disease relationship that, in turn, could provide a scientific strategy....Read More
It’s All in the Name: FDA Releases Two Guidances for Proprietary Names
Proprietary names of drugs and biologics are valuable for building the brand recognition and medication preferences of doctors and patients alike. To emphasize the importance of appropriate proprietary names, also called Brand names, of both prescription and non-prescription drugs and biologics, FDA this week released two Guidance Documents....Read More
