Scientific Publications by FDA Staff

Recent Scientific Publications

Animal and Veterinary

• BMC Vet Res 2019 May 6;15(1):130
  Enhancing the one health initiative by using whole genome sequencing to monitor antimicrobial resistance of animal pathogens: Vet-LIRN collaborative project with veterinary diagnostic laboratories in United States and Canada.
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Biologics

• J Thromb Haemost 2019 Apr;17(4):695-7
  Establishment of the WHO 2nd International Standard Factor V, plasma (16/374): communication from the SSC of the ISTH.
• Regul Toxicol Pharmacol 2019 Jul;105:62-8
  Analysis of exposure margins in developmental toxicity studies for detection of human teratogens.
• Transfusion 2019 Apr 19 [Epub ahead of print]
  New RHCE*ce variant allele in African descent holds 105C > T (silent) in cis to 48C in Exon 1 and 733G in Exon 5.
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Drugs

• Clin Pharmacol Ther 2019 May 9 [Epub ahead of print]
  A quantitative justification of similarity in placebo response between adults and adolescents with acute exacerbation of schizophrenia in clinical trials.
• J Control Release 2019 May 6 [Epub ahead of print]
  Injectable, long-acting PLGA formulations: analyzing PLGA and understanding microparticle formation.
• Int J Pharm 2019 May 6 [Epub ahead of print]
  Critical process parameters in manufacturing of liposomal formulations of amphotericin B.
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Food

• Am J Clin Nutr 2019 May 10 [Epub ahead of print]
  Monitoring vitamin D status and intake in the US population: essential to understanding the role of vitamin D in health.
• Anal Chem 2019 Apr 2;91(7):4388-4395
  Identification of Salmonella taxon-specific peptide markers to the serovar level by mass spectrometry.
• Cereal Foods World 2019 Mar-Apr;64(2):0014
  Introduction to the Food Safety Modernization Act.
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Medical Devices

• Biointerphases 2019 Mar;14(2):021007
  Toxicity and photosensitizing assessment of gelatin methacryloyl-based hydrogels photoinitiated with lithium phenyl-2,4,6-trimethylbenzoylphosphinate in human primary renal proximal tubule epithelial cells.
• BMC Genomics 2019 Apr 4;20(Suppl 2):195
  A distance-type measure approach to the analysis of copy number variation in DNA sequencing data.
• IEEE J Sel Top Quantum Electron 2019 Mar-Apr;25(2):0200204
  Introduction to the JSTQE issue on nanobiophotonics.
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Office of the Commissioner

• Clin Cancer Res 2019 May 7 [Epub ahead of print]
  FDA approval summary: glasdegib for newly-diagnosed acute myeloid leukemia.
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Regulatory Affairs

• Anal Chem 2019 Apr 2;91(7):4405-4412
  Estimating bacterial concentrations in fibrous substrates through a combination of scanning electron microscopy and ImageJ.
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Tobacco

• Int J Environ Res Public Health 2019 Apr 12;16(8):1308
  Social media mentions of Electronic Nicotine Delivery Systems (ENDS) battery-related overheating, fires, and explosions: findings from a pilot study.
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Toxicological Research

• J Am Assoc Lab Anim Sci 2018 Oct 25 [Epub ahead of print]
  Acrylamide production in autoclaved rodent feed.
• PLoS One 2019 May 7;14(5):e0216116
  In silico identification of genetic mutations conferring resistance to acetohydroxyacid synthase inhibitors: a case study of Kochia scoparia.
• Regul Toxicol Pharmacol 2019 Apr 30 [Epub ahead of print]
  Bridging communities in the field of nanomedicine.
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