Comment regarding the FDA’s proposed funding of the RADARS drug abuse surveillance system December 18, 2023
Petition to the FDA to Strengthen Safety Warning for Botox and Related Drugs and Remove Misleading Claims From Botox/Botox Cosmetic Labeling December 12, 2023
Comments Regarding the Food and Drug Administration’s Notice of Proposed Rule on Medication Guides: Patient Medication Information (FDA-2019-N-5959) November 27, 2023
Testimony Before the FDA’s Meeting of the Pulmonary-Allergy Drugs Advisory Committee Regarding Gefapixant November 17, 2023
FDA Approval of the Delandistrogene Moxeparvovec-rokl (ELEVIDYS) Gene Therapy for Duchenne’s Muscular Dystrophy Calls into Question the Agency’s Role as a Careful Gatekeeper November 1, 2023
Testimony before the Food and Drug Administration’s Cellular, Tissue, and Gene Therapy Advisory Committee regarding Exagamglogene Autotemcel Gene Therapy for Sickle Cell Disease (BLA# 125787/0, Vertex Pharmaceuticals) October 31, 2023
Testimony Before the FDA’s Nonprescription Drugs Advisory Committee Regarding the Efficacy of Oral Phenylephrine as a Nasal Congestion September 11, 2023
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Petition to the FDA to Amend the List of Drug Products That Were Withdrawn or Removed From the Market Because They Were Deemed Unsafe or Ineffective to Include Hydroxyprogesterone Caproate for Prevention of Preterm Birth April 27,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