FDA Meetings With Biosimilar Sponsors Aim To Make 351(k) Pathway OK / Short public meeting on the biosimilar user fee agreement suggests the proof will be in the scheduling. / “The Pink Sheet” DAILY Dec. 16, 2011
Transmit to Congress recommendations for a user fee program for 351(k) applications for FY 2013-2017.
Briefing Status: ON TRACK
Prior Briefing Status: ON TRACK
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Milestone Description
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Milestone Date
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Milestone Status
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Milestone Completion Date
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1. Publish Federal Register notice requesting input on the identified principles for development of a 351(k) user fee program, FDA’s proposed structure for a 351(k) user fee program that would adhere to these principles, and performance goals for this program.
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5/10/2011
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Completed
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5/10/2011
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2. Publish Federal Register notice announcing availability of the draft recommendations for user fees for 351(k) applications for fiscal years 2013-2017, with a docket to receive public comment on such recommendations; hold a meeting at which the public may present its views on such recommendations; and after consideration of such public views and comments, revise such recommendations as necessary
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12/31/2011
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On Track
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3. Transmit recommendations for user fees for 351(k) applications for fiscal years 2013-2017 to Congress
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1/15/2012
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On Track
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