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kvgreddy06 ☆ India, 2013-12-26 09:15 (4124 d 09:18 ago) Posting: # 12110 Views: 9,282 |
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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] |
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Helmut ★★★   Vienna, Austria, 2013-12-26 15:10 (4124 d 03:22 ago) @ kvgreddy06 Posting: # 12112 Views: 7,914 |
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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.
— Dif-tor heh smusma 🖖🏼 Довге життя Україна! ![[image]](https://static.bebac.at/pics/Blue_and_yellow_ribbon_UA.png) Helmut Schütz ![[image]](https://static.bebac.at/img/CC by.png) The quality of responses received is directly proportional to the quality of the question asked. 🚮 Science Quotes |
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jag009 ★★★ NJ, 2014-01-02 18:27 (4117 d 00:05 ago) @ Helmut Posting: # 12126 Views: 7,285 |
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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 Unfortunately CROs and companies (most if not all) treat the draft guidance as official, usually...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 |
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Helmut ★★★ Vienna, Austria, 2014-01-02 19:54 (4116 d 22:39 ago) @ jag009 Posting: # 12127 Views: 7,322 |
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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. — Dif-tor heh smusma 🖖🏼 Довге життя Україна! Helmut Schütz The quality of responses received is directly proportional to the quality of the question asked. 🚮 Science Quotes |
Ing. Helmut Schütz