Rituximab/hyaluronidase injection for subcutaneous use, submitted by Genentech, Inc.
Read MoreMAR 29 ODAC
Rituximab/hyaluronidase injection for subcutaneous use, submitted by Genentech, Inc.
Read MoreAPR 5 AADPAC-DSRM
Proposed Abuse-Deterrent Opioid by Inspirion Delivery Sciences
Read MoreMAR 29 ODAC
Rituximab/hyaluronidase injection for subcutaneous use, submitted by Genentech, Inc.
Read MoreMAR 15 ACPS-CP
Model-informed drug development
Read MoreMAR 29 ODAC
1) rituximab/hyaluronidase injection for subcutaneous use, submitted by Genentech, Inc. 2) binimetinib, submitted by Array BioPharma Inc (Topic 2 has since been cancelled.)
Read MoreMAR 13-14 AADPAC-DSRM
1) Safety issues with Endo's OPANA ER (extended-release (ER) oxymorphone) 2) abuse of generic oxymorphone ER and oxymorphone immediate-release (IR) products
Read MoreMAR 9 VRBPAC
Recommendations on the selection of strains to be included in the influenza virus vaccines for the 2017-2018 influenza season
Read MoreMAR 13-14 AADPAC-DSRM
1) Safety issues with Endo's OPANA ER (extended-release (ER) oxymorphone) 2) abuse of generic oxymorphone ER and oxymorphone immediate-release (IR) products
Read MoreMAR 15 ACPS-CP
Model-informed drug development
Read MoreMAR 6-7 PEDAC
Safety reviews required by BPCA/PREA/PMDSIA
Read MoreMAR 9 VRBPAC
Recommendations on the selection of strains to be included in the influenza virus vaccines for the 2017-2018 influenza season
Read MoreMAR 6-7 PEDAC
Safety reviews required by BPCA/PREA/PMDSIA
Read MoreAPR 4 NDAC-DSRM
1) Safety issues with OTC analgesics for upset stomach; and 2) Hangover indications under several monographs.
Read MoreAPR 4 NDAC-DSRM
1) Safety issues with OTC analgesics for upset stomach; and 2) Hangover indications under several monographs.
Read MoreAPR 4-5 BPAC
1) Recombinant Human Coagulation Factor IX, GlycoPEGylated 2) Blood Donor Deferral Policy for Reducing the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products 3) Research programs in the Laboratory of Emerging Pathogens in the Division of Emerging Transfusion-Transmitted Diseases
Read MoreAPR 4-5 BPAC
1) Recombinant Human Coagulation Factor IX, GlycoPEGylated 2) Blood Donor Deferral Policy for Reducing the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products 3) Research programs in the Laboratory of Emerging Pathogens in the Division of Emerging Transfusion-Transmitted Diseases
Read MoreMAR 15-16 SACHRP
1) Common Rule 2) Real-world evidence for devices
Read MoreMAR 15-16 SACHRP
1) Common Rule 2) Real-world evidence for devices
Read MoreFEB 9 ACHDNC
Newborn screening topics
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