Secretary’s Advisory Committee on Human Research Protections (SACHRP) meeting
Read MoreOCT 19 BRUDAC
Serenity Pharmaceuticals' desmopressin nasal spray for the treatment of adult onset nocturia
Read MoreOCT 13 VRBPAC
Selection of strains to be included in an influenza virus vaccine for the 2017 southern hemisphere influenza season
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 PDAC-DSRM
Review of the neuropsychiatric effects of Chantix (varenicline) and potential changes to product labeling
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 7 CTGTAC
Updates of CBER research programs
Read MoreAUG 25-26 ACHDNC
Impact of sequencing on newborn screening, screening for Lysosomal Storage Disorders, newborn screening timeliness, pilot studies for future nominated conditions, the National Contingency Plan for Newborn Screening, and working group updates
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 MoreJUL 13 AAC
Sandoz’ Biosimilar to Amgen’s ENBREL (etanercept) for rheumatoid arthrisis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, and plaque psoriasis
Read MoreJUL 12 AAC
Amgen's Biosimilar to AbbVie's Humira (adalimumab) for rheumatoid arthrisis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn's disease and plaque psoriasis
Read MoreJUN 28-29 ODAC
PWRs for (1) VENETOCLAX, application sponsored by AbbVie, Inc.; (2) TAZEMETOSTAT, application sponsored by Epizyme, Inc.; (3) ATEZOLIZUMAB, application sponsored by Roche/Genentech; (4) LOXO-101, application sponsored by Loxo Oncology, Inc.; and (5) ENTRECTINIB, application sponsored by Ignyta, Inc. Also, treatment appproaches for diffuse intrinsic pontine glioma (DIPG).
Read MoreJUN 28 EMDAC
Boehringer Ingelheim Pharmaceuticals and Eli Lilly's JARDIANCE and SYNJARDY proposed new indication to reduce CV risk
Read MoreJUN 23 PCAC
Review of 6 substances nominated for inclusion on the section 503A bulk drug substances list. Updates on discussions from previous meetings, including the option for expanded access.
Read MoreJUN 20 BPAC
Research programs in CBER's Laboratory of Plasma Derivatives
Read MoreJUN 9 AMDAC
Merck's bezlotoxumab for thethe prevention of Clostridium difficile (C. diff) infection recurrence
Read MoreJUN 8 AADPAC-DSRM
Pfizer's oxycodone/naltrexone extended-release capsules for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. It has been formulated with the intent to provide abuse-deterrent properties.
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