Scientific Publications by FDA Staff

Recent Scientific Publications

Animal and Veterinary

• AAPS PharmSciTech 2018 Oct 2 [Epub ahead of print]
  Comparing a statistical model and Bayesian approach to establish the design space for the coating of ciprofloxacin HCl beads at different scales of production.
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Biologics

• Clin Cancer Res 2018 Oct 11 [Epub ahead of print]
  FDA approval summary: tisagenlecleucel for treatment of patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia.
• Cancer Res 2018 Oct 9 [Epub ahead of print]
  A multimodal molecular imaging study evaluates pharmacological alteration of the tumor microenvironment to improve radiation response.
• Cell Rep 2018 Oct 9;25(2):312-20
  Entry, replication, immune evasion, and neurotoxicity of synthetically engineered bat-borne mumps virus.
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Drugs

• Clin Cancer Res 2018 Oct 11 [Epub ahead of print]
  FDA approval summary: tisagenlecleucel for treatment of patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia.
• J Autoimmun 2018 Oct 6 [Epub ahead of print]
  Epigenome-wide association study of peripheral blood mononuclear cells in systemic lupus erythematosus: Identifying DNA methylation signatures associated with interferon-related genes based on ethnicity and SLEDAI.
• J Biol Inorg Chem 2018 Oct 9 [Epub ahead of print]
  Correction to: The Asp99-Arg188 salt bridge of the Pseudomonas aeruginosa HemO is critical in allowing conformational flexibility during catalysis.
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Food

• Food Control 2018 Dec;94:123-31
  Evaluation of Roka Atlas Salmonella method for the detection of Salmonella in egg products in comparison with culture method, real-time PCR and isothermal amplification assays.
• J AOAC Int 2018 Oct 10 [Epub ahead of print]
  Determination of unsulfonated aromatic amines in FD&C Yellow No. 5 and FD&C Yellow No. 6 by liquid chromatography-triple quadrupole mass spectrometry.
• J AOAC Int 2018 Oct 10 [Epub ahead of print]
  Application of stable isotope dilution and liquid chromatography tandem mass spectrometry for multi-mycotoxin analysis in edible oils.
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Medical Devices

• Polymer 2018 Sep 12;152:9-17
  A hydrophilic coumarin-based polyester for ambient-temperature initiator-free 3D printing: chemistry, rheology and interface formation.
• Circulation 2018 Sep 18;138(12):1181-3
  CIED cybersecurity risks in an increasingly connected world.
• Wounds 2018 Sep 30 [Epub ahead of print]
  Key cell functions are modulated by compression in an animal model of hypertrophic scar.
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Office of the Commissioner

• Clin Cancer Res 2018 Oct 11 [Epub ahead of print]
  FDA approval summary: tisagenlecleucel for treatment of patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia.
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Regulatory Affairs

• Catheter Cardiovasc Interv 2018 Sep 23 [Epub ahead of print]
  Fracture in drug-eluting stents increases focal intimal hyperplasia in the atherosclerosed rabbit iliac artery.
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Tobacco

• Health Equity 2018 Aug 1;2(1):167-73
  Developing smokeless tobacco prevention messaging for at-risk youth: early lessons from "the real cost" smokeless campaign.
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Toxicological Research

• J Autoimmun 2018 Oct 6 [Epub ahead of print]
  Epigenome-wide association study of peripheral blood mononuclear cells in systemic lupus erythematosus: Identifying DNA methylation signatures associated with interferon-related genes based on ethnicity and SLEDAI.
• Chem Res Toxicol 2018 Sep 17;31(9):825-35
  Lipidomics reveals changes in metabolism, indicative of anesthetic-induced neurotoxicity in developing brains.
• Anal Chim Acta 2018 Dec 11;1037:87-96
  Lipidomics reveals a systemic energy deficient state that precedes neurotoxicity in neonatal monkeys after sevoflurane exposure.
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