Orphan Disclosures Could Increase Under Tweaks Proposed By FDA
This article was originally published in The Pink Sheet Daily
Agency considering whether to tell public if sponsors have submitted annual product development reports as part of proposed rule clarifying portions of 1992 Orphan Drug Regulations.
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List will include whether a designation was lost, but not why, FDA says in final rule clarifying and updated 1992 orphan drug regulations.
FDA pending actions include proposed rules on the handling of citizen petitions, eligibility for orphan drug designation and post-market safety reporting for combination products.
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.