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Mar 1 – Vaccines and Related Biological Products Advisory Committee
The Committee will discuss and make recommendations on the selection of strains to be included in the influenza virus vaccines for the 2018-2019 U.S. influenza season and hear an overview of the research program in the Laboratory of Mucosal Pathogens and Cellular Immunology (LMPCI), Division of Bacterial, Parasitic and Allergenic Products (DBPAP), Office of Vaccines Research and Review (OVRR), Center for Biologics Evaluation and Research (CBER), FDA.
Mar 5-6 – Risk Communication Advisory Committee
The Committee will discuss the impact of pregnancy and lactation labeling information in prescription drug and biological products as modified under the Pregnancy and Lactation Labeling Rule.
Mar 7 – Oncologic Drugs Advisory Committee
The Committee will discuss a supplemental biologic license applicatio for BLINCYTO (blinatumomab) injection for intravenous use, application submitted by Amgen, Inc. The proposed indication (use) for this product is for the treatment of minimal residual disease-positive B-cell precursor acute lymphoblastic leukemia.
Mar 8 – Gastrointestinal Drugs Advisory Committee
The Committee will discuss a supplemental new drug application for XELJANZ (tofacitinib) tablets, submitted by Pfizer Inc., proposed for the treatment of adult patients with moderately to severely active ulcerative colitis who have demonstrated an inadequate response, loss of response, or intolerance to corticosteroids, azathioprine, 6-mercaptopurine, or tumor necrosis factor inhibitor therapy
Mar 22 – Pediatric Advisory Committee and Endocrinologic and Metabolic Drugs Advisory Committee
The PEDAC and EMDAC will meet to discuss the major objectives of a phase 3 drug development program indicated for the treatment of children with achondroplasia (ACH). The following elements of a phase 3 program should be considered for discussion: evidence required to establish dose-response, study design, e.g., placebo control, study duration, intended population, e.g., infants and toddlers and/or older children and adolescents, and endpoints that have a clinically meaningful impact on the patient's functional or psychological well-being.
Mar 23 – Pediatric Advisory Committee
The Committee will discuss pediatric-focused safety reviews, as mandated by the Best Pharmaceuticals for Children Act (BPCA) and the Pediatric Research Equity Act (PREA). In particular, the Committee will discuss the following products (listed by FDA Center):
Center for Drug Evaluation and Research: BANZEL, INTUNIV and LEXAPRO
Center for Devices and Radiological Health: FLOURISH (Humanitarian Device Exemption (HDE)), ACTIVA (HDE), LIPOSORBER (HDE) and IMPELLA RP SYSTEM
May 10 – Endocrinologic and Metabolic Drugs Advisory Committee
The Committee will discuss the safety and efficacy of a new drug application for volanesoren solution for subcutaneous injection, submitted by Akcea Therapeutics, Inc.The proposed indication is as an adjunct to diet for the treatment of patients with familial chylomicronemia syndrome.