Testimony Before the FDA’s Peripheral and Central Nervous System Drugs Advisory Committee Regarding the Drug AMX0035 for Treatment of Amyotrophic Lateral Sclerosis March 30, 2022
Letter to Congress Regarding Legislation to Reauthorize the Medical Device User Fee Amendments March 29, 2022
Letter to Congress Regarding Legislation That Would Change the FDA’s Accelerated-Approval Program for New Drugs March 16, 2022
Presentation at the FDA’s Public Meeting on the Recommendations for Prescription Drug User Fee Act (PDUFA) Reauthorization September 28, 2021
Testimony Before the FDA’s Pharmacy Compounding Advisory Committee Regarding the List of Drug Products Withdrawn or Removed from the Market Because They Have Been Found to be Unsafe or Not Effective June 9, 2021
Comments on the FDA’s Proposal to Exclude Four Bulk Drug Substances From the 503B Bulks List for Pharmacy Compounding by Outsourced Facilities May 24, 2021
Letter to the FDA Urging the Agency Not to Approve the Biologics License Application for Donislecel for the Treatment of “Brittle” Type 1 Diabetes April 30, 2021