Regulatory Flexibility For Rare Diseases: How Do You Routinize Elasticity?
This article was originally published in The Pink Sheet Daily
FDA tries to MaPP out how and when reviewers can be flexible, moving from 'one-off' to 'boutique' evaluation.
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Rare Disease groups work to finalize white paper on accelerated approval, but FDA questions whether a rules-based biomarker qualification process is possible.
FDA may be able to talk in theoretical terms about the flexibility it is afforded for orphan products approvals, but others seem to want more tangible evidence. For its part, the agency wants more than general complaints about its regulations; it wants an open discussion of specific roadblocks.