Regulatory Flexibility Staring Contest: Will Industry Or FDA Blink First?
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.
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Attorney Frank Sasinowski says the agency should include new "boilerplate language" in official documents describing scientific flexibility for orphan drug approval requirements.
FDA should write more about its interpretation of regs and apply it more consistently across divisions, commissioner says.
Stakeholders wonder about impact of placing orphan drug program staff "into review teams" as part of next iteration of user fee program.