ISPOR is Seeking Your Input on 2 FDA Draft Guidances

February 2, 2022

The International Society for Health Economics and Outcomes Research (ISPOR) is requesting your comments on 2 FDA draft guidances. The first involves assessing real-world data registries for use in regulatory decision-making for pharma industry guidance. The second is related to the fitness of real-world data and real-world evidence for drug and biological product regulatory decision-making. The deadline for responses to be included with ISPOR’s comments is Wednesday, February 9th, 2022. The FDA accepts independent comments until March 8th, and February 28th, respectively.

According to the FDA, “Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the FDA considers your comment on a draft guidance before it begins work on the final version of the guidance, submit either online or written comments on the draft guidance before the close date.”

Click to access the surveys for the first guidance and second guidance. Links to the FDA’s draft guidances are included in the survey, but can be found in this summary.

(Source: ISPOR, January 24th, 2022)

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