FDA Staff ‘Literally’ Up At Night Deciding 3-Year Exclusivity Requests
More sponsors are submitting applications around the same time requiring the agency to make complicated decisions about exclusivity and whether approval of subsequent applications is barred, FDA attorney says.
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Jazz Disputes FDA’s Approval Of Lumryz Over Xywav’s Orphan Exclusivity, Citing Lack Of Comparative Study
Lawsuit argues FDA wrongly determined that Avadel’s Lumryz is ‘clinically superior’ to Xywav because of once-nightly dosing. FDA’s Division of Neurology revised its initial opinion based on views of CDHR’s sleep team and additional input from the agency’s orphan drug office.
Delinking pharmacy benefits managers’ compensation from the prices of drugs received bipartisan rhetorical support at a HELP markup, but the panel only cleared less drastic PBM reforms along with generic and orphan-drug focused policies. Approved amendments tackled step therapy, pharma transparency and PBM gag clauses, among other topics.
Proposals for the overhaul of the EU pharmaceutical legislation will make medicines more widely available, accessible and affordable while supporting innovation and boosting the “competitiveness and attractiveness” of Europe’s pharma industry, the European Commission claims. The research-based industry thinks otherwise, saying cuts in regulatory protections will undermine R&D.