Supplemental biologic license application for BLINCYTO (blinatumomab) injection, submitted by Amgen, Inc., proposed for the treatment of minimal residual disease-positive B-cell precursor acute lymphoblastic leukemia.
Read MoreMAR 21-22 BPAC
Reclassification of certain Human Immunodeficiency Virus (HIV) and Hepatitis C Virus (HCV) diagnostics. Presentations about research programs at the FDA's Center for Biologics Evaluation and Research (CBER).
Read MoreMAR 1 VRBPAC
1) Recommendations on the selection of strains to be included in the influenza virus vaccines for the 2018-2019 U.S. influenza season 2) Overview of the research program in the Laboratory of Mucosal Pathogens and Cellular Immunology (LMPCI), Division of Bacterial, Parasitic and Allergenic Products (DBPAP), Office of Vaccines Research and Review (OVRR), Center for Biologics Evaluation and Research (CBER), FDA
Read MoreMAR 5-6 RCAC
Impact of labeling under the Pregnancy and Lactation Labeling Rule
Read MoreFEB 14 AADPAC
sNDA for EXPAREL (bupivacaine liposomal injectable suspension) by Pacira Pharmaceuticals, Inc., to produce local analgesia and as a nerve block to produce regional analgesia
Read MoreFEB 14 AADPAC-DSRM
HYDEXOR (hydrocodone, acetaminophen, and promethazine) by Charleston Laboratories
Read MoreMAR 23 PEDAC
Safety reviews required by BPCA/PREA
Read MoreJAN 11 AMDAC
Ciprofloxacin dispersion for inhalation by Aradigm Corp.
Read MoreJAN 9 BRUDAC
Oral testosterone undecanoate capsules, submitted by Clarus Therapeutics, Inc.
Read MoreJAN 10 BRUDAC
Oral testosterone undecanoate capsules by Lipocine Inc.
Read MoreNOV 30 - DEC 1 BPAC
Bacterial risk control strategies for transfusion, device classification of human leukocyte antigen, human platelet antigen, and human neutrophil antigen devices, strategies to reduce the risk of transfusion-transmitted Zika virus, information on the Transfusion Transmissible Infections Monitoring System, and information on the FDA public workshop on emerging tick-borne diseases and blood safety
Read MoreNOV 20-21 PCAC
Nominated Bulk Substances for Compounding, Nominated Products for the Demonstrably Difficult to Compound List
Read MoreOCT 18 EMDAC
Novo Nordisk’s Semaglutide for Type 2 Diabetes
Read MoreOCT 17-18 SACHRP
Topics related to human research protections
Read MoreNOV 7 VRBPAC
Recommendations on the clinical development plan for Pfizer’s investigational Staphylococcus aureus vaccine intended for pre-surgical prophylaxis in elective orthopedic surgical populations
Read MoreOCT 13 DODAC
Rhopressa (netarsudil ophthalmic solution 0.02%) by Aerie Pharmaceuticals Inc., proposed to reduce elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension
Read MoreOCT 4 VRBPAC
Recommendations on the selection of strains to be included in an influenza virus vaccine for the 2018 Southern Hemisphere influenza season
Read MoreDEC 7 BRUDAC
Trial designs for drugs to treat interstitial cystitis and bladder pain syndrome
Read MoreOCT 12 CTGTAC
Voretigene neparvovec by Spark Therapeutics for the treatment of patients with vision loss due to confirmed biallelic RPE65 mutation-associated retinal dystrophy
Read MoreSEP 28 PCNS
Translarna (ataluren) by PTC Therapeutics for the treatment of patients with dystrophinopathy due to a nonsense mutation in the dystrophin gene
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