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Patient Experience Data (PED) in 2019-2023 US FDA NME Drug Approvals: Analysis and Recommendations.

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Title: Patient Experience Data (PED) in 2019-2023 US FDA NME Drug Approvals: Analysis and Recommendations.
Authors: Martin JD; BioMarin (United States), San Rafael, CA, USA. jewell.martin@bmrn.com., Frear D; BridgeBio (United States), Palo Alto, USA., Roberts SA; AstraZeneca (United States), Gaithersburg, MD, USA.; Genentech, Washington, DC, USA., Dohnal VA; Johnson & Johnson (United States), New Brunswick, USA., Kieffer C; Takeda (United States), Cambridge, MA, USA., Morin SL; Merck & Co., Inc., Rahway, NJ, USA., Lock I; Genentech, Washington, DC, USA., Balogun A; Johnson & Johnson (United States), New Brunswick, USA., Chhina N; BioMarin (United States), San Rafael, CA, USA.; Teva Pharmaceuticals (United States), Parsippany, NJ, USA.
Source: Therapeutic innovation & regulatory science [Ther Innov Regul Sci] 2025 Jul; Vol. 59 (4), pp. 859-870. Date of Electronic Publication: 2025 May 09.
Publication Type: Journal Article
Journal Info: Publisher: Springer International Publishing Country of Publication: Switzerland NLM ID: 101597411 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 2168-4804 (Electronic) Linking ISSN: 21684790 NLM ISO Abbreviation: Ther Innov Regul Sci Subsets: MEDLINE
Database: MEDLINE Ultimate
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  Data: Patient Experience Data (PED) in 2019-2023 US FDA NME Drug Approvals: Analysis and Recommendations.
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  Data: <searchLink fieldCode="AU" term="%22Martin+JD%22">Martin JD</searchLink>; BioMarin (United States), San Rafael, CA, USA. jewell.martin@bmrn.com.<br /><searchLink fieldCode="AU" term="%22Frear+D%22">Frear D</searchLink>; BridgeBio (United States), Palo Alto, USA.<br /><searchLink fieldCode="AU" term="%22Roberts+SA%22">Roberts SA</searchLink>; AstraZeneca (United States), Gaithersburg, MD, USA.; Genentech, Washington, DC, USA.<br /><searchLink fieldCode="AU" term="%22Dohnal+VA%22">Dohnal VA</searchLink>; Johnson & Johnson (United States), New Brunswick, USA.<br /><searchLink fieldCode="AU" term="%22Kieffer+C%22">Kieffer C</searchLink>; Takeda (United States), Cambridge, MA, USA.<br /><searchLink fieldCode="AU" term="%22Morin+SL%22">Morin SL</searchLink>; Merck & Co., Inc., Rahway, NJ, USA.<br /><searchLink fieldCode="AU" term="%22Lock+I%22">Lock I</searchLink>; Genentech, Washington, DC, USA.<br /><searchLink fieldCode="AU" term="%22Balogun+A%22">Balogun A</searchLink>; Johnson & Johnson (United States), New Brunswick, USA.<br /><searchLink fieldCode="AU" term="%22Chhina+N%22">Chhina N</searchLink>; BioMarin (United States), San Rafael, CA, USA.; Teva Pharmaceuticals (United States), Parsippany, NJ, USA.
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  Data: <searchLink fieldCode="JN" term="%22101597411%22">Therapeutic innovation & regulatory science</searchLink> [Ther Innov Regul Sci] 2025 Jul; Vol. 59 (4), pp. 859-870. <i>Date of Electronic Publication: </i>2025 May 09.
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        Value: 10.1007/s43441-025-00788-w
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              Text: 2025 Jul
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