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RegisterQ1 / Q2: CFR 320 may be of some help [Regulatives / Guidelines]
...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?
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
Kindest regards, nobody
Complete thread:
- Q1 / Q2 Guidance FDA jag009 2015-05-02 07:27
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Q1 / Q2: CFR 320 may be of some help luvblooms 2015-05-04 06:55
- Q1 / Q2: CFR 320 may be of some help jag009 2015-05-04 22:54
- Q1 / Q2: CFR 320 may be of some helpnobody 2015-05-05 11:19
- Q1 / Q2: CFR 320 may be of some help jag009 2015-05-04 22:54
- Q1 / Q2: CFR 320 may be of some help luvblooms 2015-05-04 06:55
Ing. Helmut Schütz