- 2012.04.22
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[Guidance for Industry] Guidance for Establishing Safety in First-in-Human Studies during Drug Development and Q&A documents (Published by MHLW 4/18/2012)
This Guidance and Q&A documents shows the framework of our basic concept to support the smooth t…more
- 2012.03.22
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[Guidance for Industry] Size of Beads in Drug Products Labeled for Sprinkle (Published 2/28/20112 )
The recommendations in this guidance are based on literature on chewing and swallowing particle size…more
- 2012.02.18
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[Guidance for Industry] Determining the Extent of Safety Data Collection Needed in Late Stage Premarket and Postapproval Clinical Investigations (Draft Guidance) (Published 2/9/2012 )
This guidance is intended to assist sponsors of clinical investigations in determining the amounts a…more
- 2012.02.11
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FDA has just issued three draft guidance documents on biosimilar product development to assist industry in developing such products in the United States.
These three guidance documents provide the FDA’s current thinking on key scientific and regulatory f…more





