Newsletter - December 03, 2015
New Rules from Department of Justice to Target CEOs for Non-Compliance
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 in civil or criminal courts. Read More..
FDA Slams Company for “Healthy” Label, Company Fights Back
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”. FDA objected to several other words used in the labels of Kind products such as “good”, the symbol “+”, and even the word “tasty”. Read More..
FDA Encourages Resolving Disputes with Sponsors before Legal Actions
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 with the review team. Read More..
New Rules from Department of Justice to Target CEOs for Non-Compliance
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 in civil or criminal courts. Read More..
FDA Slams Company for “Healthy” Label, Company Fights Back
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”. FDA objected to several other words used in the labels of Kind products such as “good”, the symbol “+”, and even the word “tasty”. Read More..
FDA Encourages Resolving Disputes with Sponsors before Legal Actions
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 with the review team. Read More..
