To be eligible, products must have received marketing aproval in the USA by December 31 of the year preceding the awards, but not more than 5 years earlier than December 31 of that year, unless the award is for a new and innovative indication, which must have been added within the previous 5 years.

The pharmaceutical, biotechnology, diagnostics and medical device products considered for the Prix Galien USA Award must be fully FDA approved (provisional approvals are not sufficient).

Jury Submission Criteria

Read the Charter of the Prix Galien USA Committee

Awards categories:

As many as three awards will be given for each of the following categories:

Eligibility Requirements for Digital Health*
• Clinical validations (min 2 papers) or FDA Approved
• Average annualized return of at least 20% in the past 3 years
• Turnover > $ 1 M in the past 12 months or 20% average annual growth over the past three years
• International References
• At least 10 or more employees at launch
• Have demonstrated satisfactory usage outcome (>80%)
*3 criteria must be met to be eligible

Read the Charter of the Digital Health Committee