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Restricted accessResearch articleFirst published May, 2017

A Comparison of PMDA and EMA Consultations for Regulatory and Scientific Matters in Drugs and Regenerative Medicine Products

Hideyuki Kondo, Toshiki Sugita, Naoko Ida [...]

Therapeutic Innovation & Regulatory Science

Restricted accessResearch articleFirst published November, 2018

Relationship Between the Review Time and Various PMDA Consultations in Recent New Drug Approval Cases in Japan

Keiji Nishiyama, Satoshi Toyoshima, Hiroaki Yamada [...]

Therapeutic Innovation & Regulatory Science

Restricted accessOtherFirst published January, 2009

Recent Approaches by the PMDA to Promoting New Drug Development: Change in the Status of the PMDA in Relation to New Drug Development over the Last Five Years

Kazuhiko Mori, Sotoshi Toyoshima

Therapeutic Innovation & Regulatory Science

Restricted accessResearch articleFirst published March, 2018

What to Know About Medicines With New Active Ingredients Approved in FY 2016 / 2016 in Japan and EU

Hideyuki Kondo, Agnès Saint-Raymond, Naoyuki Yasuda

Therapeutic Innovation & Regulatory Science

Restricted accessResearch articleFirst published March, 2019

Regulatory/Scientific Supports for Micro-,Small-,and Medium-Sized Enterprises (SMEs) With Medicinal Products Provided by the PMDA and EMA

Hideyuki Kondo, Masayoshi Shibatsuji, Naoyuki Yasuda

Therapeutic Innovation & Regulatory Science

Restricted accessResearch articleFirst published February, 2008

Fatal neuropsychiatric adverse reactions to oseltamivir: Case series and overview of causal relationships

Rokuro Hama

International Journal of Risk & Safety in Medicine

Search results

Articles (6)

Journals (0)

1-6 of 6 results for PMDA consultation

Sort by:

Relevance

Select all

Sort by:

Relevance

Restricted accessResearch articleFirst published May, 2017

A Comparison of PMDA and EMA Consultations for Regulatory and Scientific Matters in Drugs and Regenerative Medicine Products

Hideyuki Kondo, Toshiki Sugita, Naoko Ida [...]

Therapeutic Innovation & Regulatory Science

Restricted accessResearch articleFirst published November, 2018

Relationship Between the Review Time and Various PMDA Consultations in Recent New Drug Approval Cases in Japan

Keiji Nishiyama, Satoshi Toyoshima, Hiroaki Yamada [...]

Therapeutic Innovation & Regulatory Science

Restricted accessOtherFirst published January, 2009

Recent Approaches by the PMDA to Promoting New Drug Development: Change in the Status of the PMDA in Relation to New Drug Development over the Last Five Years

Kazuhiko Mori, Sotoshi Toyoshima

Therapeutic Innovation & Regulatory Science

Restricted accessResearch articleFirst published March, 2018

What to Know About Medicines With New Active Ingredients Approved in FY 2016 / 2016 in Japan and EU

Hideyuki Kondo, Agnès Saint-Raymond, Naoyuki Yasuda

Therapeutic Innovation & Regulatory Science

Restricted accessResearch articleFirst published March, 2019

Regulatory/Scientific Supports for Micro-,Small-,and Medium-Sized Enterprises (SMEs) With Medicinal Products Provided by the PMDA and EMA

Hideyuki Kondo, Masayoshi Shibatsuji, Naoyuki Yasuda

Therapeutic Innovation & Regulatory Science

Restricted accessResearch articleFirst published February, 2008

Fatal neuropsychiatric adverse reactions to oseltamivir: Case series and overview of causal relationships

Rokuro Hama

International Journal of Risk & Safety in Medicine