Day: September 7, 2017

Real World Evidence (RWE) and Real World Data (RWD) are very important but distinct aspects of the clinical use information available for a drug. The 21st Century Cures Act mandates FDA to use RWE in support of the approval of a product and FDA’s opinion about the utility of such data in support of market … Read more

FDA and EMA signed a mutual confidentiality arrangement this month which commits both agencies to share all information about manufacturing operations located in either region including trade secret and non-public information. The agreement will become effective on 1 Nov 2017 and will be in transition phase till July 2019 giving both agencies time to work … Read more