SEP 13 APAC

Biologics license application (BLA) for Peanut [Arachis hypogaea] Allergen Powder manufactured by Aimmune Therapeutics, Inc, indicated for treatment to reduce the risk of anaphylaxis after accidental exposure to peanut in patients aged 4 to 17 years with a confirmed diagnosis of peanut allergy

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AUG 7 AMDAC

Supplemental new drug application (sNDA) for DESCOVY (emtricitabine 200 milligrams (mg) and tenofovir alafenamide 25 mg tablets), submitted by Gilead Sciences, Inc., proposed for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 infection among individuals who are HIV-negative and at risk for HIV

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JUN 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.

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JUN 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

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MAY 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

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APR 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

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MAR 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)

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FEB 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

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