ADD Forums - Attention Deficit Hyperactivity Disorder Support and Information Resources Community  

Go Back   ADD Forums - Attention Deficit Hyperactivity Disorder Support and Information Resources Community > Blogs > wonderboy
Register Blogs FAQ Chat Members List Calendar Donate Gallery Arcade Mark Forums Read

Rate this Entry

Concerning Issues Regarding Generic Approval

Posted 08-20-17 at 06:55 PM by wonderboy
Two profoundly concerning issues with respect to generic companies receiving approval for their product


1) What is even more interesting (and, in my opinion, both unacceptable and unethical) is the "testing process" which a generic company completes in order to complete the application (an ANDA) to the FDA, for ultimate approval. Here is what I mean:

1) The generic company --alone-- performs all the tests to ensure it is commensurate with the Brand

.---This information is -------confidential------, the results are not available to the public.

One only can speculate what the: (is)

A. Internal Validity

B. External Validity

2) Once these companies begin producing their drug, most of the time
(in factories located in third world countries,) we must hope they actually produce what they state to the FDA they will. The FDA does not have the resources to check on all plants around the world.

If you visit the FDA site, in the search area, type "warning letters"- These letters are where the FDA has indeed inspected a plant, and found standards to be profoundly sub-par.




It simply makes one worry...and rightly so.....
Facebook Twitter Submit "Concerning Issues Regarding Generic Approval" to Digg Submit "Concerning Issues Regarding Generic Approval" to del.icio.us Submit "Concerning Issues Regarding Generic Approval" to StumbleUpon Submit "Concerning Issues Regarding Generic Approval" to Google
Posted in Uncategorized
Views 130 Comments 0 Email Blog Entry
« Prev     Main     Next »
Total Comments 0

Comments

 
Total Trackbacks 0

Trackbacks


All times are GMT -4. The time now is 10:47 AM.


Powered by vBulletin® Version 3.7.4
Copyright ©2000 - 2017, Jelsoft Enterprises Ltd.
(c) 2003 - 2015 ADD Forums