Trends, lag and characteristics of rare disease drug approval in the USA and China, 1983-2022. [PDF]
Orphanet J Rare DisWang S +11 more
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Letter comments on: "Twelve years of European cancer drug approval-a systematic investigation of the 'magnitude of clinical benefit'". [PDF]
ESMO Open, 2022 Müller B, Estay R.
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Response to "Anticancer Drug Approval in China: From Acceleration of Access to Certainty of Benefits". [PDF]
Health Data SciFu L, Cui Y.
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Diversity, equity, and inclusion in genitourinary clinical trials leading to FDA novel drug approval: An assessment of the FDA center for drug evaluation and research drug trials snapshot. [PDF]
Curr Probl Cancer, 2023 Matthew-Onabanjo AN +10 more
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Anticancer Drug Approval in China: From Acceleration of Access to Certainty of Benefits. [PDF]
Health Data SciZhang J.
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Analysis of racial and ethnic disparities in multiple myeloma US FDA drug approval trials. [PDF]
Blood Adv, 2022 Kanapuru B +11 more
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Orphan Drug Approval in Canada, 1999-2022: A Cross-sectional Study. [PDF]
Int J Health Policy ManagLexchin J.
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Surrogate Endpoints in Pivotal Clinical Trials for Drug Approval in Japan Compared to the United States. [PDF]
Clin Transl SciYamamoto Y, Kosaka H, Nojiri H, Maeda H.
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Assessment of the impact of Japanese-specific long-term safety data on new drug approval. [PDF]
Clin Transl Sci, 2021 Uzu S, Sekine S, Asano J, Ikuma M.
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