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U.S. Department of Health and Human Services

For Industry

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July 24, 2012

ADUFA III Negotiation Meeting Minutes
Conference Call
July 24, 2012
10:00 am – 11:30 pm

Purpose

To finalize tentative agreement for the reauthorization of ADUFA III

Participants

FDAIndustry
Steve Vaughn, FDARich Carnevale, AHI
David Wardrop, FDAChan Baldwin, Abbott
Roxanne Schweitzer, FDAGrace Gowda, Merial
Dennis Bensley, FDAKathy Vannatta, Elanco
Yanming Chae, FDASam Veluvolu, AHI
Eric Wortman, FDA 

Proposed ADUFA III Legislation and Performance Goals Letter

  • Industry and FDA agreed to final draft ADUFA III legislation.
  • Industry and FDA agreed to a few minor editorial changes to the ADUFA III performance goals letter. FDA will make those edits and forward to Industry for review.

Minor Legislative Technical Amendments

  • FDA proposed two minor legislative technical amendments FD&C Act for: 1) supporting e-Government, and 2) allowing for the aggregation of individually conditionally approved indications in a single conditionally approved product label and labeling. Industry agreed to the minor technical amendments.

ADUFA III Reauthorization Timeline

  • FDA and Industry reviewed the ADUFA III reauthorization timeline. Both agreed to the next steps and the deliverable dates.