[Previous Months][Date Index][Thread Index][Join - Register][Login]   Help@Insulin-Pumpers.org
  [Message Prev][Message Next][Thread Prev][Thread Next]   for subscribe/unsubscribe assistance
 
 

Re: [IP] Re: Disetronic D-Tron Plus freebees



Hi All,
The Spirit Pump has been available in AUSTRALIA this year.  (Since February 
?)
 when our TGA (Therapeutic Goods Administration) approved it.

Warm Regards,
Janette
----- Original Message ----- 
From: "tclickva" <email @ redacted>
To: <email @ redacted>
Sent: Saturday, July 22, 2006 1:44 PM
Subject: Re: [IP] Re: Disetronic D-Tron Plus freebees


>I don't doubt that heated words were exchanged at high levels of FDA and
> Disetronic.  And it is entirely possible that someone at FDA is holding a
> grudge against Disetronic, but there are numerous rules and regulations 
> the
> FDA must follow that require them to respond in a timely manner (usually 
> 60
> days) to company submissions.  Granted, I'm sure there are loopholes the 
> FDA
> can use to string along Disetronic but there are limits.  The purpose of 
> the
> rules is to ensure that personalities, party loyalties, grudges, etc. 
> don't
> influence FDA decisions.
>
> If the Spirit pump is approved Disetronic would no doubt need to hire more
> support staff, sales reps, etc. With no approval,  there are lost job
> opportunities in a congressional district in Indiana.  So, I think 
> Disetronic
> should talk to their Senators and representatives about the lengthy delay 
> of
> the approval process.  When congressmen lean on federal agencies they 
> almost
> always comply simply because congress controls their purse strings.
> .
.
----------------------------------------------------------
for HELP or to subscribe/unsubscribe/change list versions,
contact: HELP@insulin-pumpers.org