This session sets the context for the off-label promotion of medical products starting with early history and moving to the most recent history of FDA's decision on guidance documents.
Why should you Attend:
This class presents the latest FDA, industry & patient thinking to assist manufacturers in enhancing the predictability, consistency, and transparency of off-label promotion of medical products, and describing in greater detail the regulatory framework, policies, and practices underlying such a decision.
Areas Covered in the Session:
Snake Oil Salesmen and the FDA
FDA: between patients and industry
Off-Label Promotions and First Amendment Issues
Federal Register History of the current guidance documents
Who Will Benefit:
Small Business Owners
Angela Bazigos Seasoned Executive with 40 years of experience in the Life Sciences & Healthcare Industries. Positions include Chief Compliance Officer http://morflearning.com/angelabazigos/. Experience combines Quality Assurance, Regulatory Compliance, Business Administration, Information Technology, Project Management, Clinical Lab Science, Turnarounds and Business Development.
Event Fee: One Dial-in One Attendee Price: US$290.00
Compliance4All DBA NetZealous,