Recent And Upcoming FDA Advisory Committee Meetings
Executive Summary
Recent and upcoming US FDA advisory committee meetings and a summary of topics covered.
| Topics | Advisory Committee |
Date | Details |
|
Amendment to the emergency use authorization for Moderna's COVID-19 vaccine for administration of a booster dose in individuals 18 years of age and older |
Vaccines and Related Biological Products |
Oct. 14 (teleconference) |
(Also see "Moderna's COVID-19 Vaccine Booster US FDA Panel Nod Driven By Pragmatism" - Pink Sheet, 14 Oct, 2021.) |
|
Amendment to the EUA for Johnson & Johnson's COVID-19 vaccine for administration of a booster dose in individuals 18 years of age and older |
Vaccines and Related Biological Products |
Oct. 15 (teleconference) |
(Also see "Janssen Booster Evidence Draws Questions From US FDA, But Also A Nod Towards Benefits" - Pink Sheet, 13 Oct, 2021.) |
|
Amendment to the EUA for Pfizer's COVID-19 vaccine to allow use in children ages 5-11 years old |
Vaccines and Related Biological Products |
Oct. 26 (teleconference) |
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Continued market availability of Oncopeptides' Pepaxto (melphalan fluflenamide) for multiple myeloma in light of confirmatory trial results that suggested a detriment in overall survival |
Oncologic Drugs |
Oct. 28 (teleconference) |
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Overview of research programs in the Laboratory of Immunobiochemistry, Division of Bacterial, Parasitic and Allergenic Products in the Office of Vaccines Research and Review |
Allergenic Products |
Oct. 28 (teleconference) |
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Levo Therapeutics' carbetocin nasal spray for treatment of hyperphagia, anxiety and distress behaviors associated with Prader-Willi syndrome |
Psychopharmacologic Drugs |
Nov. 4 (teleconference) |
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Overviews of the following research programs: Plasma Derivatives Branch, Division of Plasma Protein Therapeutics in the Office of Tissues and Advanced Therapies; Laboratory of Cellular Hematology, Division of Blood Components and Devices in the Office of Blood Research and Review; Laboratory of Emerging Pathogens, Division of Emerging and Transfusion Transmitted Diseases in OBRR |
Blood Products |
Nov. 4 (teleconference) |
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Merck & Co./Ridgeback’s EUA request for molnupiravir to treat COVID-19 |
Antimicrobial Drugs |
Nov. 30 (teleconference) |
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Continued market availability of two accelerated approval drugs that have not verified clinical benefit: Secura Bio's Farydak (panobinostat) for third-line multiple myeloma and Acrotech Biopharma's Marqibo (vincristine sulfate liposome injection) for third-line treatment of Philadelphia chromosome negative (Ph-) acute lymphoblastic leukemia |
Oncologic Drugs |
Dec. 2 (teleconference) |
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|
Reata Pharmaceuticals' bardoxolone methyl capsules to slow the progression of chronic kidney disease caused by Alport syndrome in patients 12 years of age and older |
Cardiovascular and Renal Drugs |
Dec. 8 (teleconference) |