Scientific disputes are a common between sponsors and FDA reviewers. Most of the disputes occur because of interpretation of results of clinical and nonclinical studies and can be resolved with meeting the reviewers and addressing their concerns either by providing additional information or better explanation. But what should a sponsor do if there is continuing disagreement … Read more
In March of this year, FDA gave a Warning Letter to Kind LLC, the makers of Kind snack bars for use of the word “healthy” on the label of 4 of its products, among other things. FDA warned that the company does not meet the nutritional requirements defined in the law to legally call its products “healthy”. … Read more
FDA-regulated companies are subject to severe monetary and regulatory penalties when found to be non-compliant. In the last 10 years, fines of more than $20 billion were imposed just for off-label promotion by top 15 pharma companies. However, few individuals have been prosecuted, and very few senior executives have ever been personally accused of breaking the law … Read more
