Newsletter - February 04, 2016
Are GMP Sites in China Better Than Those in India?
India and China have similar number of FDA-registered GMP manufacturing sites, 662 and 694, respectively. India and China manufacture similar kind of regulated products, primarily API and finished drug products, and very few biologics and medical devices. The two countries are culturally and economically quite similar as well. However, manufacturing sites in China have received a lot fewer Warning Letters for non-compliance than those in India; 24 Warning Letters to sites in China compared to 33 letters to sites located in India. Read More..
FDA Drug and Biologic Approval at All Time High
In the year 2015, FDA approved the largest number of new drugs and biologics ever; 45 new drugs and biologics were approved. One third or 36% of these new products were first in class drugs meaning that they had novel mechanisms of action and were chemically and biologically different from any drugs approved in the past. More interesting the rate of approval; every single NDA or BLA application filed with the Agency was approved within a year indicating one of the highest success rates for marketing approval applications for two years in a row. Read More..
Are GMP Sites in China Better Than Those in India?
India and China have similar number of FDA-registered GMP manufacturing sites, 662 and 694, respectively. India and China manufacture similar kind of regulated products, primarily API and finished drug products, and very few biologics and medical devices. The two countries are culturally and economically quite similar as well. However, manufacturing sites in China have received a lot fewer Warning Letters for non-compliance than those in India; 24 Warning Letters to sites in China compared to 33 letters to sites located in India. Read More..
FDA Drug and Biologic Approval at All Time High
In the year 2015, FDA approved the largest number of new drugs and biologics ever; 45 new drugs and biologics were approved. One third or 36% of these new products were first in class drugs meaning that they had novel mechanisms of action and were chemically and biologically different from any drugs approved in the past. More interesting the rate of approval; every single NDA or BLA application filed with the Agency was approved within a year indicating one of the highest success rates for marketing approval applications for two years in a row. Read More..
