Terra Biological Pivots To Pre-IND Trials After FDA Spoils Medical Food Labeling
This article was originally published in The Rose Sheet
FDA warning letter "was a complete surprise to us, especially as we had been advising FDA of our marketing of the CRONaxal product, in writing, for approximately three years as part of our 'orphan drug designation' for glial tumors requirement," says Terra Biological CEO Alan Cook. The firm received an orphan drug designation for oxaloacetate as a treatment for gliomas in 2012.
You may also be interested in...
The trade group and food and drug attorney Scott Bass note FDA's interpretation of medical food stated in its guidance could undermine congressional intent for the category and limit the range of products firms can market as medical foods.
Marketing consultant Buzzback surveyed 800 consumers in March, prior to novel coronavirus shutdowns in the two countries, to identify ingredients that offer opportunities for brands in health care, wellness and skin care.
Firm supplying all-in-one multivitamin blends rather than packs of multiple pills has four-member advisory board including digital marketing and consumer product marketing specialists and a health care strategist.