Sanofi Aventis' PRALUENT (Alirocumab) for the treatment of high cholesterol, a PCKS9 inhibitor
Read MoreJUN 1 TSEAC
Ways to reduce the transmission risk of variant Creutzfeldt-Jakob Disease (vCJD) and bovine spongiform encephalopathy (BSE)
Read MoreMAY 13 BPAC
Testing for Babesia microti and Hemoglobin S. FDA's deferral policy for gay men. FDA research in the Laboratory of Cellular Hematology.
Read MoreMAY 12 PADAC
Vertex Pharmaceuticals' lumacaftor/ivacaftor for the treatment of cystic fibrosis (CF) in patients age 12 years and older who are homozygous for the F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene
Read MoreMAY 12 VRBPAC
Development and licensure of Ebola vaccines
Read MoreAPR 14 EMDAC
Discussion of the results from two cardiovascular outcomes trials for two DPP4 inhibitor's: AstraZeneca's saxagliptin and Takeda's alogliptin
Read MoreAPR 15 CRDAC
The Medicine Company's cangrelor for the reduction of thrombotic cardiovascular events in patients with coronary artery disease undergoing percutaneous coronary intervention
Read MoreMAR 23-24 PEDAC
How sedation in the pediatric population should be considered under the Additional Safeguards for Children in Clinical Investigations at 21 CFR 50 subpart D. Pediatric-focused reviews required by the Best Pharmaceuticals for Children Act (BPCA)
Read MoreAPR 29 CTGTAC ODAC
Amgen's talimogene laherparepvec for the treatment of patients with injectable regionally or distantly metastatic melanoma
Read MoreMAR 17 AAC
Celltrion's proposed biosimilar to Remicade
Read MoreMAR 19 PADAC-DSRM
GlaxoSmithKline's Breo Ellipta for asthma in patients 12 years of age and older. Focus is on the adequacy of the safety database.
Read MoreMAR 18 AADPAC
Organon USA Inc.'s sugamaddex for the proposed indication of reversal of moderate or deep neuromuscular blockade induced by rocuronium or vecuronium.
Read MoreMAR 9 DODAC
1) Kythera's deoxycholic acid injection 2) Pediatric development of atopic dermatitis drugs
Read MoreFEB 23-24 PCAC
Revisions to the list of drugs that may or may not be compounded and creation of the list of bulk substances that may be used to compound drug products
Read MoreMAR 4 SBFDA
Subcommittee progress reports. Regulatory science training. Bovine heparin. Science Achievement Award.
Read MoreMAR 4 VRBPAC
Strains to be included in the flu vaccines for the 2015-2016 season
Read MoreJAN 12 EMDAC
Ferring’s NOCDURNA for nocturia due to nocturnal polyuria
Read MoreJAN 7 ODAC
Sandoz (Novartis) biosimilar to Amgen's Neupogen (filgrastim)
Read MoreJAN 22 AIDAC
Astella's isavuconazonium sulfate capsules and isavuconazonium sulfate for injection, for invasive aspergillosis and mucormycosis
Read MoreDEC 18 BRUDAC-DSRM
Clinical development discussion, review of trade secret/confidential information (closed meeting)
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