Day: May 16, 2019

FDA annual report on the “State of Pharmaceutical Quality” shows that most the manufacturing sites audited by FDA have an average score of between 7-8 out of 10. Two-thirds of all drugs sold in the US are manufactured in the US, India and China with the US-based sites accounting for about 40%, those in India … Read more

It has been a common assumption that one must conduct two or more pivotal clinical trials to support the NDA or BLA for a new drug or biologic. But it is not true. About a third of NDA and BLA applications for new products approved by FDA in 2018 were based on one clinical trial … Read more