Janice Hogan

Janice Hogan

Hogan Lovells

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De Novo requests: FDA releases updated RTA checklist

On 9 September 2019 the U.S. Food and Drug Administration (FDA or the agency) issued its final guidance document entitled "Acceptance Review for De Novo Classification Requests." ...more

9/10/2019  /  De Novo Standard of Review , FDA De Novo Clearance , Food and Drug Administration (FDA) , Life Sciences , Pharmaceutical Industry

FDA proposes new regulations to govern De Novo requests – will the process live up to its promise?

Last week the Food and Drug Administration (FDA) issued a proposed set of new regulations to further define and update the De Novo review process. Although De Novo review has been available for two decades, for the past 20...more

12/13/2018  /  510(k) RTA , De Novo Standard of Review , FDA Approval , Food and Drug Administration (FDA) , Healthcare , Life Sciences , Manufacturers , Medical Devices , Pharmaceutical Industry , Standard of Review
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