FDA Supply Chain Pilots To Be Conducted By Outside Group
This article was originally published in The Pink Sheet Daily
Contractor will organize public meeting and undertake research that will inform FDA's guidance on unit-level tracing.
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Agency planned for up to 100 participants in program allowing expedited entry of some imports, but only approved 13.
Pink Sheet Podcast: FDA User Fee Bill Mark-Up, Postmarket Quality Requirements, Fewer Adcom Meetings
Pink Sheet reporter and editors discuss the first mark-up of the House FDA user fee bill, the likelihood of more postmarketing quality requirements for drug manufacturers, and the significance of the shrinking number of FDA advisory committee meetings.
The must-pass bill has many FDA policy ornaments hanging from it, but the version released by Democratic and Republican committee leadership has notable absences as well, including Cures 2.0.