FDA Should Reject Accelerated Approval of the Gene Therapy SRP-9001 as a Treatment for Ambulatory Duchenne Muscular Dystrophy (DMD) June 15, 2023
Petition to the FDA to Amend the List of Drug Products That Were Withdrawn or Removed From the Market Because They Were Deemed Unsafe or Ineffective to Include Hydroxyprogesterone Caproate for Prevention of Preterm Birth April 27, 2023
Letter to the FDA Urging Postponement of the Approval Decision Regarding Lecanemab for Treatment of Alzheimer’s Disease January 4, 2023
Letter to the FDA Opposing Approval of Daprodustat and Other Hypoxia-Inducible Factor Prolyl Hydroxylase Inhibitors December 14, 2022
Testimony Before the FDA’s Cardiovascular and Renal Drugs Advisory Committee Regarding Omecamtiv Mecarbil For the Treatment of Heart Failure December 13, 2022
Follow-up Comments to the FDA Regarding CDER’s Proposal to Withdraw Approval of Makena (Hydroxyprogesterone Caproate) November 2, 2022
Testimony Before the FDA’s Cardiovascular and Renal Drugs Advisory Committee Regarding Daprodustat for the Treatment of Anemia Due to Chronic Kidney Disease October 26, 2022
Testimony Before the FDA’s Psychopharmacologic Drugs Advisory Committee Regarding Pimavanserin for the Treatment of Hallucinations and Delusions in Alzheimer’s Disease Psychosis June 17, 2022
Letter to Congress Calling for the Retention of a House-Passed Provision in H.R. 4521, the America COMPETES Act, That Would Give the FDA Mandatory Recall Authority For All Drugs May 20, 2022