Newsletter - February 1, 2018
Can You Sue FDA for Negative Audit Findings? Indian Company Tests US Legal System
Negative FDA audits could have catastrophic consequences for the companies at the receiving end. It could lead to drastic financial losses, loss of credibility and even push the defaulter out of business. If a company is destroyed by a negative FDA audit, can it sue FDA for damages? Read More
Some States to Allow Off Label Promotion of Drugs: Headache for FDA?
Three states, Mississippi, Missouri and Colorado recently proposed bills to allow off-label promotion of drugs. These states are following on the lead established by Arizona that passed a law last March to allow drug companies to legally promote off-label uses of FDA-approved products (drugs, biologics and medical devices) without any fear of prosecution.. Read More
Can You Sue FDA for Negative Audit Findings? Indian Company Tests US Legal System
Negative FDA audits could have catastrophic consequences for the companies at the receiving end. It could lead to drastic financial losses, loss of credibility and even push the defaulter out of business. If a company is destroyed by a negative FDA audit, can it sue FDA for damages? Read More
Some States to Allow Off Label Promotion of Drugs: Headache for FDA?
Three states, Mississippi, Missouri and Colorado recently proposed bills to allow off-label promotion of drugs. These states are following on the lead established by Arizona that passed a law last March to allow drug companies to legally promote off-label uses of FDA-approved products (drugs, biologics and medical devices) without any fear of prosecution.. Read More
