Scientific Publications by FDA Staff

Recent Scientific Publications

Animal and Veterinary

• BMC Genomics 2020 Aug 6;21(1):544
  Using full chloroplast genomes of 'red' and 'yellow' Bixa orellana (achiote) for kmer based identification and phylogenetic inference.
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Biologics

• JAMA 2020 Aug 7 [Epub ahead of print]
  Unwavering regulatory safeguards for COVID-19 vaccines.
• NPJ Vaccines 2020 Jun 18;5:52
  WHO informal consultation on the guidelines for evaluation of the quality, safety, and efficacy of DNA vaccines, Geneva, Switzerland, December 2019.
• Sci Transl Med 2020 Jul 29;12(554):eaax2550
  Scientific considerations for global drug development.
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Drugs

• Int J Toxicol 2020 Aug 7 [Epub ahead of print]
  Drug development 101: a primer.
• Dry Technol 2020 Jul 16 [Epub ahead of print]
  Integrated use of mechanistic models and targeted experiments for development, scale-up and optimization of lyophilization cycles: a single vial approach for primary drying.
• Int J Pharm 2020 Aug 2 [Epub ahead of print]
  Influence of residual solvents on the physical properties of transdermal drug delivery systems.
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Food

• BMC Genomics 2020 Aug 6;21(1):544
  Using full chloroplast genomes of 'red' and 'yellow' Bixa orellana (achiote) for kmer based identification and phylogenetic inference.
• J Am Oil Chem Soc 2020 Jun 23 [Epub ahead of print]
  Regulatory changes affecting the production and use of fats and oils: focus on partially hydrogenated oils.
• Sci Total Environ 2020 Nov 25;(745):104795
  A systematic review of post-harvest interventions for Vibrio parahaemolyticus in raw oysters.
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Medical Devices

• Analyst 2020 Aug 7 [Epub ahead of print]
  3D-printed phantoms for characterizing SERS nanoparticle detectability in turbid media.
• PLoS One 2020 Aug 3;15(8):e0236784
  A computational study to model the effect of electrode-to-auditory nerve fiber distance on spectral resolution in cochlear implant.
• Plast Reconstr Surg 2020 Aug;146(2):255-67
  Toward international harmonization of breast implant registries: international collaboration of breast registry activities global common data set.
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Office of the Commissioner

• JAMA 2020 Aug 7 [Epub ahead of print]
  Unwavering regulatory safeguards for COVID-19 vaccines.
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Regulatory Affairs

• Clin Infect Dis 2020 Jun 21[Epub ahead of print]
  Outbreak of norovirus gastroenteritis associated with ice cream contaminated by frozen raspberries from China; Minnesota, USA, 2016.
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Tobacco

• J Adolesc Health 2020 Aug 1 [Epub ahead of print]
  School use and normative perceptions of electronic nicotine product use among middle and high school students--November 2018.
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Toxicological Research

• Nucleic Acids Res 2020 Aug 4 [Epub ahead of print]
  A comprehensive rat transcriptome built from large scale RNA-seq-based annotation.
• J Toxicol Sci 2020;45(8):435-47
  Gene expression profiling in dorsolateral prostates of prepubertal and adult Sprague-Dawley rats dosed with estradiol benzoate, estradiol, and testosterone.
• Eur J Med Chem 2020 Oct 15;204:112599
  Design, synthesis and high antitumor potential of new unsymmetrical bisacridine derivatives towards human solid tumors, specifically pancreatic cancers and their unique ability to stabilize DNA G-quadruplexes.
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