FDA released a new internal policy on 17th Aug whereby sponsors of ANDA applications will soon start receiving timely updates regarding the status of their application’s review. Under this new policy the Regulatory Project Managers (RPMs) at Office of Generic Drugs (OGD) will respond to any status inquiries from authorized representatives of the companies within 2 … Read more
On 18th August FDA finally approved Addyi (flibanserin) popularly known as the “Female Viagra”. Third time was the charm for the manufacturer, Sprout Pharma, who learnt from there previous two failures and gamed the Advisory Committee using aggressive campaign to claim that their product should be approved despite all the safety concerns and marginal effectiveness because there was … Read more
Kim Kardashian tweets about a morning sickness drug and the world goes crazy. By this time, if you have not heard about it, you may be the only one in the world. But this is not the first time celebrity endorsements have been used by companies to make misleading claims. Celebrities are used to sell all … Read more
