kvgreddy06
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India,
2013-12-26 09:15
(3745 d 08:10 ago)

Posting: # 12110
Views: 7,951
 

 ANDA Submissions-RTR (Refuse to Receive) [BE/BA News]

Dear All

RTR (Refuse to Receive) is going to be comes in effect from 02nd January 2014.

http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm370352.pdf


Edit: Unlinked from an unrelated thread. [Helmut]
Helmut
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Vienna, Austria,
2013-12-26 15:10
(3745 d 02:15 ago)

@ kvgreddy06
Posting: # 12112
Views: 6,835
 

 Failed studies, alternate designs

Hi kvgreddy06,

THX for reminding us!

❝ […] is going to be comes in effect from 02nd January 2014.


Where do you get this information from? It’s a draft and 20 comments have been submitted so far (although none are posted at regulations.gov yet).

Understandably the FDA wants to decrease its workload refusing failed and alternate designs without previous correspondence*.

line 640: FDA will refuse to receive an ANDA if only a failed study is submitted.
644–647: Submitting a non-recommended in vivo study without adequate justification will result in FDA refusing to receive an ANDA. We encourage applicants to consult the BE recommendations webpage for product-specific study information or to contact the Division of Bioequivalence via Control Correspondence for further guidance if needed.



  • In my experience mainly fishy attempts to “safe” a failed study by post-hoc changing the primary targets (PK metrics, metabolites, …).

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jag009
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NJ,
2014-01-02 18:27
(3737 d 22:57 ago)

@ Helmut
Posting: # 12126
Views: 6,277
 

 Failed studies, alternate designs

Happy New Year Helmut!

Laszlo (Endrenyi) said Hi. I had dinner with him while I was in Toronto Canada.

❝ ❝ […] is going to be comes in effect from 02nd January 2014.


❝ Where do you get this information from? It’s a draft and 20 comments have been submitted so far..


Unfortunately CROs and companies (most if not all) treat the draft guidance as official, usually...

John
Helmut
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Vienna, Austria,
2014-01-02 19:54
(3737 d 21:31 ago)

@ jag009
Posting: # 12127
Views: 6,311
 

 Jan 2nd, 2014?

Happy New Year John!

❝ Laszlo (Endrenyi) said Hi. I had dinner with him while I was in Toronto Canada.


THX! I have to wait until May to meet him again…

❝ ❝ ❝ […] is going to be comes in effect from 02nd January 2014.

❝ ❝ Where do you get this information from? It’s a draft and 20 comments have been submitted so far..

❝ Unfortunately CROs and companies (most if not all) treat the draft guidance as official, usually...


Yes, right. In this particular case I’m completely with the FDA. Must be a nightmare to review all this “creative inventions” (attempts to get failed studies through). So CROs should take this (draft) guidance seriously.
My original question was about the “effective date = today”, which I could not find anywhere at FDA’s site.

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