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
Petition to the FDA to Amend the List of Drug Products That Were Withdrawn or Removed From the Market Because They Were Deemed Unsafe or Ineffective April 13, 2021
Letter to the Secretary of Health and Human Services Requesting an Investigation of the FDA’s Inappropriate Close Collaboration with Biogen on the Alzheimer’s Disease Drug Aducanumab April 1, 2021
Testimony before the FDA’s Arthritis Advisory Committee and Drug Safety and Risk Management Advisory Committee Regarding Tanezumab for Treatment of Osteoarthritis March 24, 2021
Comments for the FDA’s March 24-25, 2021 Joint Meeting of the Arthritis Advisory Committee and the Drug Safety and Risk Management Advisory Committee Regarding Biologics License Application for the Osteoarthritis Drug Tanezumab March 10, 2021
Testimony Before the FDA’s Vaccines and Related Biological Products Advisory Committee Regarding the EUA of the Janssen COVID-19 Vaccine February 26, 2021
Letter to the Editor of JAMA Neurology Regarding Lack of Clarity Regarding the Disclosure of Financial Conflicts of Interest February 23, 2021
Follow-up Letter to the FDA’s Acting Commissioner Regarding the Agency’s Inappropriate Close Collaboration with Biogen on the Alzheimer’s Disease Drug Aducanumab January 28, 2021