Day: March 22, 2018

Earlier this year, the Associate Attorney General at the Department of Justice (DOJ) instructed its staff to not initiate civil enforcement action against any party based on Guidance Documents, a decision that can have an enormous impact on the FDA regulated industry. There are 4220 Guidance Documents available on FDA’s web site; more than a … Read more

This week FDA posted a full clinical study report (CSR) included in an NDA approved last month for prostate cancer drug ERLEADA. In this new pilot transparency program FDA plans to similarly publish CSRs for eight more newly approved drugs aiming to provide more usable information about clinical trial design, statistical analysis, and other operational … Read more