Quality

FDA Asks for Input on Trial Designs for EIDs

Following the 2014 Ebola outbreak, the FDA is weighing the best options for testing and rapidly deploying treatments for emerging infectious diseases and wants to hear from you on the subject. Read More

WHO Releases Draft Guidance on Global Data Integrity

Good data integrity practices are drawing attention on a global scale, as the World Health Organization — with the help of international regulators — has released draft guidance that attempts to bridge gaps between the principles of good data and record management and actual practices. Read More

FDA Seeks Feedback on Trial Designs for EIDs

In the wake of the 2014 Ebola outbreak, the FDA is weighing the best options for testing and rapidly deploying treatments for emerging infectious diseases and wants to hear from you on the subject. Read More

Details on Sandoz Warning Letter Reveal Gaping Data Integrity Gaps

On Tuesday, the FDA released the Oct. 22 warning letter issued to Sandoz sites in Kalwe and Turbhe, Maharashtra, India, which Sandoz had earlier hinted at during its third quarter earnings call. With the release of the warning letter, the extent of the data integrity issues are now known. Read More