Meeting With FDA Can Increase the Probability of Product Approval

Posted 01 October 2010 | By

Formal meetings with reviewers at the US Food and Drug Administration (FDA) are among the most important and useful resources available to sponsors of medicinal products seeking marketing approval in the US. These meetings provide an opportunity for companies to discuss product development strategies with the regulators and clarify interpretations of the regulations. In 1997, under the Prescription Drug User Fee Act (PDUFA), the US Congress mandated FDA meetings with applicants to guide and assist them in planning and submitting appropriate information in all the steps leading to marketing a medicinal product.1 Since then, FDA personnel have participated in hundreds of meetings each year covering all kinds of applications. Although this article uses drug terminology, the information applies to biological products, medical devices, generics, over-the-counter drugs and all other products regulated by FDA.

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