Amy Dow Quoted in "US FDA Shows Willingness to Be Flexible in Using Foreign Device Clinical Trial Data"

The Food and Drug Administration's draft guideline on acceptance of medical device clinical trial data from studies conducted outside the US (OUS) is a positive for the industry and shows the US agency's increased willingness to be flexible on this topic, says Amy K Dow from law firm Epstein Becker & Green. …

Particularly useful in the draft guideline are the hypothetical scenarios in which the FDA describes the various types of OUS clinical data that companies can include in their submissions, the challenges associated with the use of such data, additional analysis or additional data that companies may be asked to collect when submitting OUS, and the outcomes of the applicant's collaborative efforts with the FDA in these hypothetical scenarios. In many of these examples, the applicant companies were permitted to use the OUS clinical data to meet requirements for the submission, either in full or with additional analysis, Ms Dow notes.

"These scenarios remind applicants of the importance of early collaboration with FDA when seeking to use OUS clinical data, as well an increased willingness on the part of FDA to be flexible and work with applicants to utilize existing data. This level of collaboration by FDA and applicants may result in a reduction in the number of studies that need to be repeated to meet FDA's requirements… The question remains whether [current] resource levels at FDA will limit the Agency's ability to collaborate fully with applicants in the manner described in the draft guidance," Ms Dow told Scrip Regulatory Affairs.