JP drafts for public comments, September 30 - October 30, 2019
New general information
- Bacterial Endotoxins Test and alternative methods using recombinant protein-reagents for endotoxin assay (001-1909-2eng.pdf)
JP drafts for public comments, September 30 - December 30, 2019
New monographs
- Cloperastine Fendizoate (002-1909-2eng.pdf)
- Cloperastine Fendizoate Tablets (003-1909-2eng.pdf)
- Eribulin Mesilate (004-1909-2eng.pdf)
Briefing on Proposed Draft
Official Monograph “Eribulin Mesilate”
- Phenobarbital Tablets (005-1909-2eng.pdf)
- Pitavastatin Calcium Orally Disintegrating Tablets (006-1909-2eng.pdf)
- Silodosin Orally Disintegrating Tablets (007-1909-2eng.pdf)
Ultraviolet-visible reference spectra
- Cloperastine Fendizoate (008-1909-2eng.pdf)
Infrared reference spectra
- Cloperastine Fendizoate (009-1909-2eng.pdf)
To send the comment on these drafts, the guidance is as follows:
- Download the form for comments in Word format
- Fill in the form
- Prepare and attach the supportive data that scientifically validate the comment when appropriate
- Send it to the email address: JPdraft1909-2eng●pmda.go.jp
Note: For the purpose of security, this email address is partly incorrect. Please replace ● with @ when sending an email.
Related Information
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