You’ve received “the call” from the FDA auditor. After an understandable quick moment of panic, what should your next steps be?
For some it’s hard to remember life before the internet. Having access to endless amounts of “resources” and knowledge, instant “friends” with those thousands of miles away, and the ability to always be in-step with those you “follow”- all have revolutionized the modern day world. Recent warning letters issued by FDA urge the industry to take cautionary steps when navigating this new World Wide Web frontier.
This whitepaper examines the similarities and differences between various US and international regulations and place them within the context of any number of roles found within the realm of clinical research.