Fda to have hearing on combo

[Aboveallislove]

http://www.gpo.gov/fdsys/pkg/FR-2015-03-31/pdf/2015-07272.pdf

Y

 

[Gammaw]

Thanks for the link AboveAll. Do you know if there is a way to get automatic updates or notifications from the Federal Register or the FDA on things related to CF meds?

 

[Aboveallislove]

I think I saw a place to request on fda but not positive what you can ask to get updates on. Who would've thought the federal register could be so important or exciting!!! ;-)

 

[Joe2007]

Thanks so much for posting this link. It should be of great interest to many.

 

[Rickengelage]

So they gonna discuss on may 15 wether or not they approve?

I didnt quiete get what the page was saying?

Can someone tell me more about what exactly gonna happen?

 

[Aboveallislove]

Yes. The fda uses an advisory committee with a special expertise in the area to review everything and make recommendations to fda. Then the fda decides in a month or so. Fda usually follows recommendations. The law requires public notice and to allow public comments which is what I'm trying to push...public comment by CFer encouraging committee to recommend approval.

 

[Aboveallislove]

Rick,here's an example of what the advisory committee does in context of the kalydeco expansion
http://www.fda.gov/downloads/Adviso...y-AllergyDrugsAdvisoryCommittee/UCM422838.pdf

http://www.fda.gov/downloads/Adviso...y-AllergyDrugsAdvisoryCommittee/UCM433343.pdf

 

[Rickengelage]

Thanks! So after the recommandation is to approve it and the fda decides to approve in a month or so, it will actually be available??
After that?

Or theres more waiting time for something else after that before we can get it?

 

[Aboveallislove]

If you are in us, then once fda approves then it is just a matter of getting a script, doing pre authorization which is ddf508 over 11 is just a process not a matter of they can deny, and then getting a pharmacy t fill...might have little delays for all of this in that cf clinc might only script during a quarterly appointment, vertx might need a few weeks to get to harm any, pre autho might take a couple weeks, etc.

 

[Rickengelage]

Sounds awesome, finally progress, i thought it would take atleast another year, maybe two.

But now we might have acces to the med this summer?
With a bit of lick ofcourse!
It would be awesome

 

[Aboveallislove]

I'm hoping! Another thought...you might want to discuss with your cf doctor at your next appointment that you want as soon as it is approved and ask whether you can call in for script at that point.

 

[CFPapaPia]

Thanks for the information.