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jag009 ★★★ NJ, 2015-05-02 09:27 (4075 d 11:16 ago) Posting: # 14746 Views: 12,540 |
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Hi, Does anyone know if there is some kind of FDA guidance on Q1 and Q2? I searched around and only find bits and pieces of information... Thanks John |
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luvblooms ★★ India, 2015-05-04 08:55 (4073 d 11:49 ago) @ jag009 Posting: # 14747 Views: 11,214 |
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Hi John ❝ Does anyone know if there is some kind of FDA guidance on Q1 and Q2? I searched around and only find bits and pieces of information... As of now even I am not aware of any specific Q1/Q2 guidance but there are sufficient information available in CFR's. Do check these links
Hope this would be of some help!!! — ~A happy Soul~ |
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jag009 ★★★ NJ, 2015-05-05 00:54 (4072 d 19:50 ago) @ luvblooms Posting: # 14748 Views: 10,835 |
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Thanks Bloom, Yes I found those info as well. John |
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nobody nothing 2015-05-05 13:19 (4072 d 07:25 ago) @ jag009 Posting: # 14749 Views: 10,848 |
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...some more: http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm370352.pdf (with cross-ref to CFR) http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/AbbreviatedNewDrugApplicationANDAGenerics/UCM292571.pdf ...comes down to request controlled correspondence for Q1/Q2, or? — Kindest regards, nobody |
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