These instructions were on the document labeled changes
I have clarified and attached the required documents as the writer did not make the changes and continued to not
make the changes
as itinally stated this is part 2 of the indication module
I need the changes done not like how it was initially which is copy and paste from the sample indication module.
Please confirm that you are working on it as soon as possible.
Please check the file 267012 | Changes.doc .
These changes were not done 4. Using the medical reviews and pivotal trial documents please fill in the
highlighted sections Under section 3.0 Global Regulatory Strategic Considerations and use the attached
documents named : Rytary pivotal trial, Duopa pivotal , Northera pivotal study, Nuplazid pivotal study ,Northera
medical review,Nuplazid Medical Review, Rytary medical review, and duopa medical review.
1. In the Section 2.2.1 Precedent Pivotal Trial Designs please provide a summary of all the conclusion of the
clinical trial data using the attached documents called Rytary pivotal trial, Duopa pivotal , Northera pivotal study
and Nuplazid pivotal study.
2. In section 2.1.3 Applications referred to advisory committees/scientific advisory groups please add a
summary in Table ÕÉ≠†Њ†2.c of the attached document called advisory committee Northera
3. In section 2.5 Health Authority Guidance’s and Communications Related to Indication under 188.8.131.52 please
use the information found http://www.aafp.org/afp/2007/0315/p922.html and fill in the table. Also under section
184.108.40.206 Europe use the guidance attached named indication related guidance documents Parkinson and create a
table like the one provided.
4. Using the medical reviews and pivotal trial documents please fill in the highlighted sections Under section 3.0
Global Regulatory Strategic Considerations and use the attached documents named : Rytary pivotal trial, Duopa
pivotal , Northera pivotal study, Nuplazid pivotal study ,Northera medical review,Nuplazid Medical Review, Rytary
medical review, and duopa medical review.
please make the changes
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