Day: November 12, 2015

Since the passing of Tobacco Control Act in 2009, FDA has been actively and aggressively going after all tobacco products. Last week we discussed in details the actions FDA has taken to strictly regulate sale of tobacco products, primarily cigarettes. One thorn on FDA’s side has been e-cigarettes which currently FDA cannot regulate. In the 2009, FDA … Read more

Two weeks ago, I wondered if Indian GMP manufacturers are indeed as bad as one would be led to believe based on the constant headline news of FDA’s audit notices to manufacturing sites in India. A review of FDA’s inspections database shows that the truth may be somewhere in the middle. Indian GMP sites are found to have issues … Read more