Originally Published MX
September/October 2003

Government &
Legal Affairs

To avoid premature, overoptimistic, or other problematic disclosure of potentially false or misleading information emerging from clinical studies, medtech company executives should:



• Restrict access to sensitive information to only those who need to know.

• Make public announcements only when products are in late stages of clinical development.

• Create a written corporate disclosure policy.

• Train employees to observe the policy.

• Consult FDA whenever in doubt. 

Copyright ©2003 MX