Log in
Register|
jag009 ★★★ NJ, 2015-05-02 09:27 (4069 d 17:04 ago) Posting: # 14746 Views: 12,534 |
|
|
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 |
|
luvblooms ★★ India, 2015-05-04 08:55 (4067 d 17:36 ago) @ jag009 Posting: # 14747 Views: 11,206 |
|
|
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~ |
|
jag009 ★★★ NJ, 2015-05-05 00:54 (4067 d 01:37 ago) @ luvblooms Posting: # 14748 Views: 10,828 |
|
|
Thanks Bloom, Yes I found those info as well. John |
|
nobody nothing 2015-05-05 13:19 (4066 d 13:12 ago) @ jag009 Posting: # 14749 Views: 10,839 |
|
|
...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 |
Ing. Helmut Schütz