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Regulations & Services of PMDA
Information about Approved Products in Japan
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Information for approved products in Japan
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Development of Drugs, Medical devices, Regenerative medicines and in Vitro diagnostics
Information for approved products in Japan
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Regulations and services of PMDA
Information for approved products in Japan
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Regulations and Services of PMDA
Information for apporoved products in Japan
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Regulations and Services of PMDA
Information for apporoved products in Japan
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Reviews and Related Services
Post-marketing Safety Measures
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Reviews and Related Services
Post-marketing Safety Measures
Regulatory Science/The Science Board/Standard Development
The 4th Subcommittee on Placebo-controlled Studies
Press Release
Date and Time: May 8, 2015 from 3pm to 5pm
Agenda / List of Handouts
Agenda
- Current situation of placebo-controlled studies
- Placebo-controlled studies from the perspective of medical statistics
- Others
List of Handouts
- Document 1 Status of sponsor initiated placebo-controlled studies - what is the practical concerns? -
- Document 2 Potential issues in non-inferiority studies