Citizen Petition from Buchanan Ingersoll & Rooney PC
Details
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- Title
- Citizen Petition from Buchanan Ingersoll & Rooney PC
- Posted
- Mar 4, 2026
- Comment period
- Mar 4, 2026 – ?
Overview
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Stance breakdown
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| Organization | Citizen petition requirements |
|---|
1 organization-typed comment could not be identified.
Explorer
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- Jun 2, 2026Comment from Outsourcing Facilities AssociationOpposeTrade association📎 Attachment
The Outsourcing Facilities Association (OFA), a trade association representing FDA-registered outsourcing facilities, opposes the citizen petition requesting enforcement action against facilities distributing repackaged Avastin. They argue that the products are repackaged, not compounded, and that the FDA already has an appropriate regulatory framework in place via its Biologics Repackaging Guidance.
Read comment → - Apr 7, 2026Comment from OUTSOURCING FACILITIES ASSOCIATIONOpposeTrade association📎 Attachment
The Outsourcing Facilities Association (OFA), a trade association representing 503B outsourcing facilities, opposes the citizen petition filed by Buchanan Ingersoll & Rooney PC. They argue that the petition is legally deficient, fails to provide required "exact wording" for requested actions, lacks necessary unfavorable information, and would negatively impact patient access to affordable medications.
Read comment →