You’ve received “the call” from the FDA auditor. After an understandable quick moment of panic, what should your next steps be?
Topics: Warning Letter, Audit Prep, BIMO Checklist, FDA

You want to keep your trial on track, but physical distancing and travel restrictions have made it difficult. Fortunately, IMARC has experience providing remote services.
You’ve received “the call” from the FDA auditor. After an understandable quick moment of panic, what should your next steps be?
Topics: Warning Letter, Audit Prep, BIMO Checklist, FDA
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.
Topics: Warning Letter, social media, FDA