Recent And Upcoming FDA Advisory Committee Meetings
Executive Summary
Recent and upcoming FDA advisory committee meetings and a summary of topics covered.
Topic |
Advisory Committee |
Date |
Sandoz’s EP2006, a proposed biosimilar to Amgen’s Neupogen (filgrastim), for the following proposed indications: to decrease the incidence of infection‚ as manifested by febrile neutropenia‚ in patients with nonmyeloid malignancies receiving myelosuppressive cancer drugs with a significant incidence of severe neutropenia with fever; for reducing the time to neutrophil recovery and duration of fever following induction or consolidation chemotherapy in adults with acute myeloid leukemia; to reduce duration of neutropenia and neutropenia-related clinical sequelae‚ e.g.‚ febrile neutropenia, in patients with nonmyeloid malignancies undergoing myeloablative chemotherapy followed by marrow transplantation; for the mobilization of hematopoietic progenitor cells into the peripheral blood for collection by leukapheresis; and for chronic administration to reduce the incidence and duration of sequelae of neutropenia (e.g.‚ fever‚ infections‚ oropharyngeal ulcers) in symptomatic patients with congenital neutropenia‚ cyclic neutropenia‚ or idiopathic neutropenia |
Oncologic Drugs |
Jan. 7 |
Ferring Pharmaceuticals’ Nocdurna (desmopressin) orally disintegrating sublingual tablets for treatment of nocturia due to nocturnal polyuria in adults who awaken two or more times each night to void |
Endocrinologic and Metabolic Drugs |
Jan. 12 |
Astellas Pharma Global Development’s isavuconazonium sulfate capsules and injection for treatment of invasive aspergillosis and mucormycosis |
Anti-Infective Drugs |
Jan. 22 |
Influenza virus vaccine strain selection for the 2015-2016 flu season |
Vaccines and Related Biological Products |
March 4 |
Progress report or a final draft report from the Commissioner's Fellowship Program Evaluation subcommittee; progress report from the Science Moving Forward subcommittee; FDA's public access policy; approaches to regulatory science training coordination; activities regarding the re-introduction of bovine heparin; overview of science-related activities from one of the centers; presentation by a recipient of the Fiscal Year 2014 Scientific Achievement Awards |
Science Board |
March 4 |