Review of substances nominated for the list of bulk substances allowed for compounding and products nominated for the difficult to compound list
Read MoreAPR 13 AMDAC
Development of antibacterial drugs that treat a single species of bacteria when the target species infrequently causes infections
Read MoreAPR 5 AADPAC-DSRM
Proposed abuse-deterrent oxycodone immediate-release oral tablets, submitted by Inspirion Delivery Sciences, LLC
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 NDAC-DSRM
1) Safety issues with OTC analgesics for upset stomach; and 2) Hangover indications under several monographs.
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 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 6-7 PEDAC
Safety reviews required by BPCA/PREA/PMDSIA
Read MoreFEB 9 ACHDNC
Newborn screening topics
Read MoreDEC 6 BRUDAC
Clinical trial design features, including acceptable endpoints for demonstrating clinical benefit, for drugs intended to treat secondary hypogonadism while preserving or improving testicular function, including spermatogenesis
Read MoreNOV 17-18 BPAC
Strategies to manage iron deficiency with blood donation; Adverse reactions in teen donors; Zika and blood safety; Workshop updates
Read MoreNOV 15 SBFDA
The Science Board will hear about: (1) The Center for Biologics Evaluation and Research’s strategic goals for regulatory science; (2) a progress update on FDA’s Opioid Action Plan and the Bovine Heparin Initiative; (3) a response from the Office of Scientific Professional Development to the Science Board’s report on the Commissioner’s Fellowship Program; (4) a report from the Scientific Engagements Subcommittee; and (5) a report from the Food Emergency Response Network Cooperative Agreement Program Evaluation Subcommittee.
Read MoreNov 7 RCAC
FDA’s draft Strategic Plan for Risk Communication and Health Literacy
Read MoreNOV 4 AMDAC
Cempra Pharmaceuticals' solithromycin capsules & injection for community-acquired bacterial pneumonia
Read MoreNOV 3-4 ACHDNC
Advisory Committee on Heritable Disorders in Newborns and Children (ACHDNC) meeting
Read MoreNOV 3 PCAC
Review of substances nominated for the list of bulk substances allowed for compounding and products nominated for the difficult to compound list
Read MoreNOV 2-3 CLIAC
Updates from the Centers for Disease Control and Prevention (CDC), the Centers for Medicare and Medicaid Services (CMS), and the Food and Drug Administration (FDA).
Read MoreOCT 27 APAC
Updates of CBER research programs
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