Supplemental new drug application for nintedanib capsules (drug name OFEV), by Boehringer Ingelheim, for the treatment of systemic sclerosis-associated interstitial lung disease
Read MoreJUN 20 ODAC
#1 Review of two target “classes” on the mandated list of relevant pediatric molecular targets: 1) targets linked to cell lineage; and 2) targets on normal immune cells and cells in the tumor microenvironment.
#2 Discussion of information pertinent to the potential development of Pediatric Written Requests (PWRs) for two investigational cancer products, ONC201 and CD24Fc.
Read MoreJUN 6 AMDAC
Pretomanid tablets for oral administration, submitted by The Global Alliance for TB Drug Development, Inc. (TB Alliance), proposed as part of a combination regimen with bedaquiline and linezolid in adults for the treatment of pulmonary extensively drug resistant and treatment-intolerant or non-responsive multidrug-resistant tuberculosis
Read MoreJUN 11-12 AADPAC-DSRM
Opioid Prescribing and Potential Risk Mitigation Strategies
Read MoreMAY 14 ODAC
Pexidartinib capsule by Daiichi Sankyo, Inc., proposed for the treatment of adult patients with symptomatic tenosynovial giant cell tumor
Quizartinib tablets by Daiichi Sankyo, Inc., proposed for the treatment of adults with relapsed or refractory acute myeloid leukemia, which is FLT3-ITD positive, as detected by an FDA-approved test
Read MoreMay 7 ACPS-CP
Approaches to evaluate the effect of renal impairment on drug exposure and best practice considerations for translating pharmacokinetic (PK) information into dose individualization instructions
Read MoreMAY 8 PADAC
Mannitol inhalation powder for cystic fibrosis
Read MoreAPR 26 AMDAC
Safety and effectiveness of bacitracin for intramuscular injection
Read MoreAPR 25 AMDAC
Pathways for approval of rabies virus monoclonal antibodies for use as the passive-immunization component of post-exposure prophylaxis
Read MoreAPR 15-16 ACBTSA
Review of the Public Health Service Guidelines on Reducing HIV, HBV, and HCV through Organ Transplantation
Read MoreAPR 10-11 CLIAC
Update from the CDC’s Office of Infectious Diseases (OID) Board of Scientific Counselors meeting and reports from three CLIAC workgroups: the Clinical Laboratory Improvement Amendments (CLIA) Personnel Regulations Workgroup, the Nontraditional Testing Workflow Model Workgroup, and the Next Generation Sequencing (NGS) Workgroup
Read MoreAPR 8 PEDAC
Drug development for testosterone replacement therapy in male adolescents with classic hypogonadism
Read MoreMAR 22 ACHDNC
Condition nomination and evidence review process; Implementation of RUSP conditions
Rare disease registries
Read MoreMAR 20-21 BPAC
Discussion of whether universal testing of blood donations for ZIKV is an appropriate strategy considering the decline of the epidemic
Overview of the research programs in the Laboratory of Biochemistry and Vascular Biology in the Division of Blood Components and Devices, Office of Blood Research and Review, CBER, FDA
Blood donation policies regarding men who have sex with men (MSM)
Read MoreFEB 26 ODAC
Selinexor tablets, submitted by Karyopharm Therapeutics, Inc., for use, in combination with dexamethasone, in the treatment of patients with relapsed refractory multiple myeloma who have received at least three prior therapies and whose disease is refractory to at least one proteasome inhibitor, at least one immunomodulatory agent, and an anti-CD38 monoclonal antibody
Read MoreFEB 12 PDAC-DSRM
Esketamine nasal spray, submitted by Janssen Pharmaceuticals, Inc., for the treatment of treatment-resistant depression.
Read MoreMAR 27 PADAC
PRE-PEN PLUS, a proposed skin test kit for penicillin allergy by AllerQuest
Read MoreJAN 17 EMDAC
Zynquista (sotagliflozin) oral tablet, sponsored by Sanofi-Aventis U.S., LLC (Sanofi), for the proposed indication of use as adjunct to insulin therapy to improve glycemic control in adults with type 1 diabetes mellitus. Zynquista is being developed in partnership with Lexicon Pharmaceuticals, Inc.
Read MoreJAN 16 BRUDAC
EVENITY (romosozumab) injection, submitted by Amgen, for the treatment of osteoporosis in postmenopausal women at high risk for fracture, defined as a history of osteoporotic fracture, or multiple risk factors for fracture; or patients who have failed or are intolerant of other available osteoporosis therapy
Read MoreJAN 11 AAC-DSRM
Cardiovascular Safety of Takeda’s Gout Drug, Uloric (febuxostat)
Read More