Presentations on CBER Research Programs
Read MoreJUL 18-19 BPAC
Bacterial risk control strategies to enhance the safety and availability of platelets for transfusion. Potential reclassification of nucleic acid and serology-based point-of-care and laboratory-based in vitro diagnostic devices indicated for use as aids in the diagnosis of human immunodeficiency virus (HIV) infection.
Read MoreJUN 20 ODAC
Review of proposed molecular targets for pediatric drug development that may be required under the Pediatric Research Equity Act
Read MoreMAY 17 VRBPAC
1) Approaches for demonstrating effectiveness of group B streptococcus (GBS) vaccines intended for use in pregnant women to protect the newborn infant
2) Overview of the research program in the Laboratory of Respiratory Viral Diseases (LRVD), Division of Viral Products, Office of Vaccines Research and Review, CBER, FDA
Read MoreMAY 1 AMDAC
Tecovirimat, by SIGA Technologies Inc., for the treatment of smallpox
Read MoreAPR 23 SBFDA
Hear about the CBER Program Review Subcommittee report; Hear about FDA’s Patient Affairs Initiative; Obtain advice to leverage existing tools and authorities, and work with stakeholders, to better address the complex scientific, public health, and technology challenges FDA faces today
Read MoreAPR 24-25 AAC DSRM
sNDA for CELEBREX (celecoxib), by Pfizer, Inc., which includes the results from the PRECISION (Prospective Randomized Evaluation of Celecoxib Integrated Safety vs. Ibuprofen Or Naproxen) trial
Read MoreMAY 22 AADPAC-DSRM
Buprenorphine sublingual spray, by INSYS Development Company, for the treatment of moderate-to-severe acute pain where the use of an opioid analgesic is appropriate
Read MoreMAY 3 GIDAC-PEDAC
Atannsoporfin intramuscular injection, by InfaCare Pharmaceutical Corp, for neonates ≥ 35 weeks of gestational age with indicators of hemolysis who are at risk of developing severe hyperbilirubinemia
Read MoreMAY 2 AMDAC
Plazomicin, by Achaogen,Inc., for the proposed indications for the treatment of complicated urinary tract infections and blood stream infections
Read MoreAPR 10-11 CLIAC
Updates from the CDC, CMC and FDA. Presentations and discussion on other topics of interest to clinical laboratories.
Read MoreAPR 23 AAC
Baricitinib tablets, submitted by Eli Lilly and Company, proposed for the treatment of adult patients with moderately 5 to severely active rheumatoid arthritis who have had an inadequate response or intolerance to methotrexate
Read MoreAPR 19 PCNS
Cannabidiol oral solution, sponsored by GW Pharmaceuticals, proposed for the adjunctive treatment of seizures associated with Lennox-Gastaut syndrome or Dravet syndrome in patients 2 years of age and older
Read MoreMAR 27 PDAC
Lofexidine hydrochloride, submitted by US WorldMeds, LLC, for mitigation of symptoms associated with opioid withdrawal and facilitation of completion of opioid discontinuation treatment
Read MoreMAY 10 EMDAC
Volanesorsen solution for subcutaneous injection, submitted by Akcea Therapeutics, Inc., proposed as an adjunct to diet for the treatment of patients with familial chylomicronemia syndrome.
Read MoreMAR 7 ODAC
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 MoreFEB 8 ACHDNC
Issues related to newborn screening (NBS) and the diagnosis and treatment of individuals with heritable disorders
Read MoreMAR 5-6 RCAC
Impact of labeling under the Pregnancy and Lactation Labeling Rule
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