Yasuhiro Fujiwara

Chief Executive

Pharmaceuticals and Medical Devices Agency

Japan

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Yasuhiro Fujiwara is the Chief Executive at the Pharmaceuticals and Medical Devices Agency in Japan. His research areas include drug development, oncology, and regulatory assessments related to regenerative medicine and artificial organs. He has authored several articles addressing topics such as the safety and efficacy of drug use in oncology and the perspectives of the PMDA on current medical innovations. His work focuses on balancing regulatory efficiency with patient safety in the evolving pharmaceutical landscape.

Articles (11)

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2025

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2023

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2021

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2021

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2021

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2021

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2020

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2020

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2020

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2020

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2020

Collaborators (4)

Mototsugu Tanaka

Associate Professor

Niigata University Medical and Dental Hospital

JAPAN

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Mutsuhiro IKUMA

Pharmaceuticals and Medical Devices Agency

JAPAN

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Yoshiaki Uyama

Pharmaceuticals and Medical Devices Agency

JAPAN

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Daisuke Tanaka

Osaka University

JAPAN

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Yasuhiro Fujiwara

Research Interests

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Articles (11)

Expediting Drug Development in Japan: A PMDA Perspective

Challenges in Expediting the Development of Oncology Drugs

The PMDA Perspectives on New Oral Prolyl Hydroxylase Domain Enzyme Inhibitors for Renal Anemia

Safety and Evidence of Off-Label Use of Approved Drugs at the National Cancer Center Hospital in Japan

Balancing Safety and Efficacy With Early Availability in the Regulation of Regenerative Medicine Product

No-fault compensation schemes for COVID-19 medical products

BRCA1 promoter methylation in breast cancer patients is associated with response to olaparib/eribulin combination therapy

CYP2D6 genotype-guided tamoxifen dosing in hormone receptor-positive metastatic breast cancer (TARGET-1): A randomized, open-label, Phase II study

Cardiac Safety of the Trastuzumab Biosimilar ABP 980 in Women with HER2-Positive Early Breast Cancer in the Randomized, Double-Blind, Active-Controlled LILAC Study

Future development of artificial organs related with cutting edge emerging technology and their regulatory assessment: PMDA’s perspective

Her3 protein expression as a risk factor for post-operative recurrence in patients with early-stage adenocarcinoma and adenosquamous carcinoma of the cervix

Collaborators (4)

Mototsugu Tanaka

Mutsuhiro IKUMA

Yoshiaki Uyama

Daisuke Tanaka

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