FDA Supplement Beverage Guidance May Open Can Of Regulatory Worms
This article was originally published in The Pink Sheet Daily
Executive Summary
A product's size and shape, phrases such as "drink" and "juice," and other similarities to conventional beverages may invoke food rather than supplement regulations, FDA says in guidance addressing concerns that by labeling products as supplements, some firms are circumventing the costly GRAS process required for conventional foods
You may also be interested in...
Cancer-Genomics Firm Quanticel Debuts With Close Ties To Celgene, And An Exit In Mind
Celgene will get exclusive use of Quanticel's single-cell genomic analysis to tweak its clinical pipeline, and it also has exclusive options to acquire the venture-backed start-up.
One Trial Plus Supportive Evidence Is Enough For Hospital-, Ventilator-Acquired Pneumonia Indication, Panel Says
Anti-Infective Drugs Advisory Committee members viewed one-trial as practical means of gaining efficacy data.
Otsuka Busulfex's Overall Survival Claim Does Not Survive CDER Advertising Scrutiny
Statistical analyses based on pivotal trial data and used to promote a drug must prove what they purport to prove, FDA's Office of Prescription Drug Promotion says in an NOV letter to Otsuka over a website for the leukemia drug Busulfex (busulfan).