Scientific Publications by FDA Staff

Recent Scientific Publications

Animal and Veterinary

• Rapid Commun Mass Spectrom 2019 Oct 28 [Epub ahead of print]
  Proteomics profiling of swine serum following lipopolysaccharide stimulation.
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Biologics

• mSphere 2019 Sep 25;4(5):e00520-19
  Glycoconjugates: what it would take to master these well-known yet little-understood immunogens for vaccine development.
• Biologicals 2019 Nov 4 [Epub ahead of print]
  Global harmonization of vaccine testing requirements: making elimination of the ATT and TABST a concrete global achievement.
• Viruses 2019 Nov 1;11(11):1016
  A single point mutation in the mumps V protein alters targeting of the cellular STAT pathways resulting in virus attenuation.
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Drugs

• Pharm Res 2019 Nov 14;36(12):180
  Stratum corneum sampling to assess bioequivalence between topical acyclovir products.
• Mutat Res 2019 Dec;848:503106
  Pig-a mutations in bone marrow erythroblasts of rats treated with 7,12-dimethyl-benz[a]anthracene.
• J Pediatr 2019 Nov 7 [Epub ahead of print]
  Standardizing safety assessment and reporting for neonatal clinical trials.
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Food

• Braz J Microbiol 2019 Nov 15 [Epub ahead of print]
  Phylogenetic analysis revealed that Salmonella Typhimurium ST313 isolated from humans and food in Brazil presented a high genomic similarity.
• Microorganisms 2019 Nov 12;7(11):554
  Prevalence, distribution, and phylogeny of type two toxin-antitoxin genes possessed by Cronobacter species where C. sakazakii homologs follow sequence type lineages.
• PeerJ 2019 Nov 5;7:e7827
  Evaluation of variation within the barcode region of cytochrome C oxidase I (COI) for the detection of commercial Callinectes sapidus Rathbun, 1896 (blue crab) products of non-US origin.
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Medical Devices

• Am Heart J 2019 Dec;218:110-22
  Claims-based cardiovascular outcome identification for clinical research: results from 7 large randomized cardiovascular clinical trials.
• JAMA Cardiol 2019 Nov 13 [Epub ahead of print]
  The march of transcatheter aortic valve replacement therapy--US Food and Drug Administration perspectives on device approval for patients at low surgical risk.
• J Biopharm Stat 2019 Nov 10 [Epub ahead of print]
  Propensity score-integrated composite likelihood approach for incorporating real-world evidence in single-arm clinical studies.
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Office of the Commissioner

• J Pediatr 2019 Nov 7 [Epub ahead of print]
  Standardizing safety assessment and reporting for neonatal clinical trials.
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Regulatory Affairs

• J Microbiol Methods 2019 Nov 8 [Epub ahead of print]
  A real-time PCR for rapid identification of Salmonella enterica Gaminara serovar.
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Tobacco

• Toxicol Appl Pharmacol 2019 Nov 12 [Epub ahead of print]
  Use of a physiologically-based pharmacokinetic model to explore the potential disparity in nicotine disposition between adult and adolescent nonhuman primates.
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Toxicological Research

• Toxicol Appl Pharmacol 2019 Nov 12 [Epub ahead of print]
  Use of a physiologically-based pharmacokinetic model to explore the potential disparity in nicotine disposition between adult and adolescent nonhuman primates.
• Arch Toxicol 2019 Nov 13 [Epub ahead of print]
  The landscape of hepatobiliary adverse reactions across 53 herbal and dietary supplements reveals immune-mediated injury as a common cause of hepatitis.
• Int J Environ Res Public Health 2019 Nov 8;16(22):4361
  Persistent organic pollutants in food: contamination sources, health effects and detection methods.
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