Labeling change - PMC

Rie Matsui, Koji Yamaguchi, Jadz Jevz Venzon Lee, Ivy Ting, Destita Khairilisani, Jenny Chang, Jeong-Min Seo, Ina Park, Alice Seat Mee Chee, Paul Marvin Quizon, Usanee Harnpramukkul, Ellen Sem, Thuy Nguyen, Anagha Padhye, Runyi Mo

Ther Innov Regul Sci. 2023; 57(2): 251–260. Published online 2022 Oct 10. doi: 10.1007/s43441-022-00462-5

Correction in:: Ther Innov Regul Sci. 2023; 57(2): 261.

PMCID:: PMC9549856

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A 15 Year Review (2006–2020) of Patient-Reported Outcome (PRO) in United States Oncology Product Labeling and Trends in Sponsor Size and Oncology Experience

Lisa Cooper, Emily Wo, Irene Lee

Arch Intern Med Res. Author manuscript; available in PMC 2023 Apr 14.

Published in final edited form as: Arch Intern Med Res. 2022; 5(3): 412–419. Published online 2022 Aug 11. doi: 10.26502/aimr.0123

PMCID:: PMC10104564

Article PDF–283K

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Elements of Regulatory Dissonance: Examining FDA and EMA Product Labeling of New Vaccines (2006–2018)

Yurim Seo, Eunjoo Pacifici

Vaccine. 2020 Nov 3; 38(47): 7485–7489. Published online 2020 Oct 13. doi: 10.1016/j.vaccine.2020.09.067

PMCID:: PMC7550305

Article PDF–359K

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Food Allergy Labeling Laws: International Guidelines for Residents and Travelers

Francesca Chang, Lauren Eng, Christopher Chang

Clin Rev Allergy Immunol. 2023 May 9 : 1–18. doi: 10.1007/s12016-023-08960-6 [Epub ahead of print]

PMCID:: PMC10169132

Abstract Article PDF–2.1M

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MedDRA Labeling Groupings to Improve Safety Communication in Product Labels

Ilona Große-Michaelis, Scott Proestel, Radhika M. Rao, Brian S. Dillman, Silvia Bader-Weder, Lynn Macdonald, William Gregory

Ther Innov Regul Sci. 2023; 57(1): 1–6. Published online 2022 Aug 8. doi: 10.1007/s43441-022-00393-1

PMCID:: PMC9810671

Article PDF–623K

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Pharmacogenomic Biomarkers: an FDA Perspective on Utilization in Biological Product Labeling

Robert N. Schuck, Joseph A. Grillo

AAPS J. 2016 May; 18(3): 573–577. Published online 2016 Feb 24. doi: 10.1208/s12248-016-9891-4

PMCID:: PMC5256609

Article PDF–253K

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Clinical pharmacology information in regulatory submissions and labeling: A comparative analysis of orphan and non‐orphan drugs approved by the FDA

Julie Hsieh, Martina Sahre, Xinning Yang, Rajanikanth Madabushi, Anuradha Ramamoorthy

Clin Transl Sci. 2022 Nov; 15(11): 2583–2596. Published online 2022 Sep 27. doi: 10.1111/cts.13362

PMCID:: PMC9652444

Article PDF–678K

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Tracer-based estimates of protein flux in cases of incomplete product renewal: evidence and implications of heterogeneity in collagen turnover

Haihong Zhou, Sheng-Ping Wang, Kithsiri Herath, Takhar Kasumov, Rovshan G. Sadygov, Stephen F. Previs, David E. Kelley

Am J Physiol Endocrinol Metab. 2015 Jul 15; 309(2): E115–E121. Published online 2015 May 26. doi: 10.1152/ajpendo.00435.2014

PMCID:: PMC4596733

Article

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An Interactive User Interface for Drug Labeling to Improve Readability and Decision-Making

Hamed Abedtash, Jon D. Duke

AMIA Annu Symp Proc. 2015; 2015: 278–286. Published online 2015 Nov 5.

PMCID:: PMC4765573

Article PDF–726K

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Metabolic Flux Analysis—Linking Isotope Labeling and Metabolic Fluxes

Yujue Wang, Fredric E. Wondisford, Chi Song, Teng Zhang, Xiaoyang Su

Metabolites. 2020 Nov; 10(11): 447. Published online 2020 Nov 6. doi: 10.3390/metabo10110447

PMCID:: PMC7694648

Article PDF–2.7M

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Americans’ Perspectives on Online Media Warning Labels

Jeremy Straub, Matthew Spradling

Behav Sci (Basel) 2022 Mar; 12(3): 59. Published online 2022 Feb 23. doi: 10.3390/bs12030059

PMCID:: PMC8945542

Article PDF–19M

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Structured Product Labeling Improves Detection of Drug-intolerance Issues

Gunther Schadow

J Am Med Inform Assoc. 2009 Mar-Apr; 16(2): 211–219. doi: 10.1197/jamia.M2933

Correction in:: J Am Med Inform Assoc. 2009 Jul-Aug; 16(4): 605.

PMCID:: PMC2649322

Article PDF–328K

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Utilization of adequate provision in prescription drug broadcast ads among low- and non-Internet users: Health Marketing Quarterly

Kevin R. Betts, Kathryn J. Aikin, Panne Burke, Stephanie Miles, Shane Mannis

Health Mark Q. Author manuscript; available in PMC 2022 Sep 14.

Published in final edited form as: Health Mark Q. 2022 Jan-Mar; 39(1): 4–22. Published online 2021 Oct 18. doi: 10.1080/07359683.2021.1989747

PMCID:: PMC9472712

Article PDF–352K

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Science‐Based Approach to Harmonize Contraception Recommendations in Clinical Trials and Pharmaceutical Labels

Christopher J. Bowman, Nathalie Becourt‐Lhote, Virginie Boulifard, Rüdiger Cordts, Solange Corriol‐Rohou, Brian Enright, Linda Erkman, Jayne Harris, Andreas Hartmann, Jan Hilpert, Sophie Kervyn, Britta Mattson, LaRonda Morford, Mireille Muller, Marcy Powell, Zhanna Sobol, Rajamuthu Srinivasan, Claudia Stark, Kary E. Thompson, Katie J. Turner, Paul Barrow

Clin Pharmacol Ther. 2023 Feb; 113(2): 226–245. Published online 2022 May 5. doi: 10.1002/cpt.2602