Drug Approval Package: RAYALDEE (Calcifediol)
Jan 5, 2017 5:41:14 GMT
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sgard434, thought013, and 2 more like this
Post by stcks on Jan 5, 2017 5:41:14 GMT
The FDA released the "Drug Approval Package" for Rayaldee on January 03, 2017.
This is all the data, correspondence and paperwork from last spring. They have blocked out items which are private.
It is ALL history. There are some OLD documents there that had not been released yet.
Reading through, these are a great "case study" to analyze to illustrate how both OPKO and FDA worked in this event.
They release it to the public in one location so you can see it after everything is done.
I looked at some of the pages. I know that there are others that understands all the information.
There a lot here so I can't post all the sheets.
Let's have fun!
Follow the link
www.accessdata.fda.gov/drugsatfda_docs/nda/2016/208010Orig1_toc.cfm
Company:  OPKO Ireland Global Holdings Ltd.
Application No.:  208010Orig1
Approval Date: June 17, 2016
Persons with disabilities having problems accessing the PDF files below may call (301) 796-3634 for assistance.
* Approval Letter(s) (PDF)
* Other Action Letters (PDF)
* Printed Labeling (PDF)
* Summary Review (PDF)
* Officer/Employee List (PDF)
* Medical Review(s) (PDF)
* Chemistry Review(s) (PDF)
* Pharmacology Review(s) (PDF)
* Statistical Review(s) (PDF)
* Clinical Pharmacology Biopharmaceutics Review(s) (PDF)
* Proprietary Name Review(s) (PDF)
* Other Review(s) (PDF)
* Administrative Document(s) & Correspondence(PDF)
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This is all the data, correspondence and paperwork from last spring. They have blocked out items which are private.
It is ALL history. There are some OLD documents there that had not been released yet.
Reading through, these are a great "case study" to analyze to illustrate how both OPKO and FDA worked in this event.
They release it to the public in one location so you can see it after everything is done.
I looked at some of the pages. I know that there are others that understands all the information.
There a lot here so I can't post all the sheets.
Let's have fun!
Follow the link
www.accessdata.fda.gov/drugsatfda_docs/nda/2016/208010Orig1_toc.cfm
Company:  OPKO Ireland Global Holdings Ltd.
Application No.:  208010Orig1
Approval Date: June 17, 2016
Persons with disabilities having problems accessing the PDF files below may call (301) 796-3634 for assistance.
* Approval Letter(s) (PDF)
* Other Action Letters (PDF)
* Printed Labeling (PDF)
* Summary Review (PDF)
* Officer/Employee List (PDF)
* Medical Review(s) (PDF)
* Chemistry Review(s) (PDF)
* Pharmacology Review(s) (PDF)
* Statistical Review(s) (PDF)
* Clinical Pharmacology Biopharmaceutics Review(s) (PDF)
* Proprietary Name Review(s) (PDF)
* Other Review(s) (PDF)
* Administrative Document(s) & Correspondence(PDF)
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