The new FDA commissioner Scott Gottlieb said brand name drug companies are “gaming the system” to block generic competition and vowed to do something about it.  https://www.usatoday.com/story/news/politics/2017/08/15/fda-chief-says-drug-makers-gaming-system-slow-generic-competition-vows-action/568698001/ The EMA Committee for Human Medicinal Products (CHMP) adopted an updated guideline on what manufacturing process information should be included in the marketing authorization application (MAA). http://raps.org/Regulatory-Focus/News/2017/08/14/28239/EMA’s-CHMP-Adopts-Updated-Guideline-on-Manufacture-of-Finished-Dosage-Form Pfizer[…]