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Originally Published MX September/October 2003

Government & Legal Affairs

Disclosure Management

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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. 

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