Letter to Senior FDA and NIH officials Urging Changes to the Fact Sheets for Recipients of the Recently Authorized COVID-19 Vaccines December 22, 2020
Testimony Before the FDA’s Vaccines and Related Biological Products Advisory Committee Regarding the EUA of the Moderna-NIH COVID-19 Vaccine December 17, 2020
Testimony Before the FDA’s Vaccines and Related Biological Products Advisory Committee Regarding the EUA of the Pfizer-BioNTech COVID-19 Vaccine December 10, 2020
Letter to the FDA Regarding the Agency’s Inappropriate Close Collaboration with Biogen on the Alzheimer’s Disease Drug Aducanumab December 9, 2020
Letter to the HHS Office of Inspector General Requesting an Investigation of the FDA’s Inappropriate Close Collaboration with Biogen on the Alzheimer’s Disease Drug Aducanumab December 9, 2020
Testimony Before the FDA’s Drug Safety and Risk Management Advisory Committee and Anesthetic and Analgesic Drug Products Advisory Committee Regarding a Hydrocodone-Acetaminophen-Promethazine Combination Product November 2, 2020
Testimony Before the FDA’s Vaccines and Related Biological Products Advisory Committee Regarding the Development, Authorization, and Licensure of Vaccines to Prevent COVID-19 October 22, 2020
Testimony Before the FDA’s Psychopharmacologic Drugs Advisory Committee and Drug Safety and Risk Management Advisory Committee Regarding the Combination Drug Olanzapine/Samidorphan Intended to Treat Schizophrenia and Bipolar Disorder October 9, 2020
Testimony Before the FDA’s Psychopharmacologic Drugs Advisory Committee and Drug Safety and Risk Management Advisory Committee Regarding an Oral Amphetamine Product Intended to be Abuse-Deterrent October 8, 2020