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 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 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 4 AMDAC
Cempra Pharmaceuticals' solithromycin capsules & injection for community-acquired bacterial pneumonia
Read MoreOCT 27 APAC
Updates of CBER research programs
Read MoreOCT 19 BRUDAC
Serenity Pharmaceuticals' desmopressin nasal spray for the treatment of adult onset nocturia
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 MoreOCT 5 AADPAC-DSRM
Most appropriate dose or doses of naloxone products to reverse the effects of life - threatening opioid overdose in all ages
Read MoreSEP 15-16 PEDAC/AADPAC/DSRM
Development plans for establishing the safety and efficacy of prescription opioid analgesics for pediatric patients, including obtaining pharmacokinetic data and the use of extrapolation
Read MoreSEP 14 ODAC
Spectrum's apaziquone for immediate intravesical instillation post-transurethral resection of bladder tumors in patients with non-muscle invasive bladder cancer
Read MoreSEP 14 PEDAC
Pediatric-focused safety reviews
Read MoreSEP 14 PDAC-DSRM
Review of the neuropsychiatric effects of Chantix (varenicline) and potential changes to product labeling
Read MoreSEP 7 CTGTAC
Updates of CBER research programs
Read MoreAUG 4 AADPAC-DSRM
Egalet's morphine sulfate extended-release tablets with proposed abuse-deterrent formulation
Read MoreJUL 26 CTGTAC
Updates of research programs in the Laboratory of Molecular Oncology and the Laboratory of Biological Chemistry, Division of Biotechnology Review and Research 1 and 4, Office of Biotechnology Products, CDER
Read MoreJUL 19 DODAC
Valeant’s brodalumab for plaque psoriasis
Read More