Ashley Slagle, MS PhD, and Robyn von Maltzahn, MSc
Regulatory and Health Technology Assessment Engagement (R&HE) SIG Co-Chairs
The R&HE SIG is pleased to announce that we have provided comments to the docket on FDA’s Patient Focused Drug Development Draft Guidance 3: Patient-Focused Drug Development: Selecting, Developing, or Modifying Fit-for-Purpose Clinical Outcome Assessments. The comments we provided reflected the views of multiple contributors and reflect the SIG’s interest in engaging with regulators (and other stakeholders) on matters of policy that address critical outcome measurement issues. FDA reviews all comments to the docket when they endeavor to update a draft guidance into a final guidance, so it was important that we shared our views on the positive elements in the guidance as well as where we saw room for improvements. The PFDD guidance series is an important set of guidances, reflecting FDA’s commitment to patient focused drug development. PFDD draft guidance 4 – the final in this series – is expected to be released soon, and the SIG plans to provide comments on that guidance as well. If you are interested in participating in that comment period, please join the SIG and/or stay tuned, we will be reaching out as soon as the draft guidance 4 publishes! In the meantime, here is the link to the comments we provided on draft guidance 3, also available on the ISOQOL Resource Center:
The R&HE SIG Meeting will be held on Friday, 21 October from 11:40 am – 12:40 pm.
This newsletter editorial represents the views of the author and do not necessarily reflect the views of ISOQOL.
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