Disclosure Management

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:

o Restrict access to sensitive information to only those who need to know.
o Make public announcements only when products are in late stages of clinical development.
o Create a written corporate disclosure policy.
o Train employees to observe the policy.
o Consult FDA whenever in doubt. 

Copyright ©2003 MX