11/15/2024

OFA Comment to FDA on semaglutide shortage

10/31/2024

OFA urges the FDA to take stakeholder feedback into account to develop a comprehensive understanding of outsourcing facilities 

10/24/2024

OFA Comments on Citizen Petition from Covington & Burling LLP on Behalf of Novo Nordisk Inc. to highlight that the FDA Commissioner and the American public have an interest to know the effects on cost and price that Novo’s requested action would have on consumers.

06/18/2024

OFA Comment to FDA on Drug Products or Categories of Drug Products that Present Demonstrable Difficulties for Compounding

01/08/2024

OFA Comment to FDA on Interim Policy on Compounding Using Bulk Drug Substances Under Section 503B

08/28/2023

OFA Comment to FDA on Prohibition on Wholesaling 

01/23/2023

OFA Comment to FDA urging the FDA to define "clinical need"

01/05/2022

OFA Comments on Citizen Petition from Nexus Pharmaceuticals Inc

12/06/2021

OFA Comments on FDA’s revised draft guidance on Hospital and Health System Compounding Under Section 503A of the Federal Food, Drug, and Cosmetic Act