Newborn screening topics
Read MoreFEB 9 ACHDNC
Newborn screening topics
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 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 6-7 PEDAC
Safety reviews required by BPCA/PREA/PMDSIA
Read MoreFEB 16 PDAC
Valbenazine for the proposed treatment of Tardive Dyskinesia, submitted by Neurocrine Biosciences, Inc.
Read MoreFEB 16 PDAC
Valbenazine for the proposed treatment of Tardive Dyskinesia, submitted by Neurocrine Biosciences, Inc.
Read MoreMAR 15 ACPS-CP
Model-informed drug development
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 MoreMAR 15 ACPS-CP
Model-informed drug development
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 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
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