ADUFA III Negotiation Meeting Minutes
July 24, 2012
10:00 am – 11:30 pm
To finalize tentative agreement for the reauthorization of ADUFA III
|Steve Vaughn, FDA||Rich Carnevale, AHI|
|David Wardrop, FDA||Chan Baldwin, Abbott|
|Roxanne Schweitzer, FDA||Grace Gowda, Merial|
|Dennis Bensley, FDA||Kathy Vannatta, Elanco|
|Yanming Chae, FDA||Sam 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.