OCT 9 VRBPAC

1) ) Overview of the research programs in the Laboratory of Hepatitis Viruses (LIR) and the Laboratory of Vector-Borne Viral Diseases (LVVD), Division of Viral Products, Office of Vaccines Research and Review, CBER, FDA

2) Recommendations on the selection of strains to be included in an influenza virus vaccine for the 2020 southern hemisphere influenza season

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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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