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RegisterQ1 / Q2: CFR 320 may be of some help [Regulatives / Guidelines]
Hi John
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!!!
❝ 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
- Excipients: A Regulatory Support Prospective: Many CFR links are given for Solution, opthalmics and injections
- Criteria for waiver of evidence of in vivo bioavailability or bioequivalence.
- 21 CFR 320.22 - Criteria for waiver of evidence of in vivo bioavailability or bioequivalence
Hope this would be of some help!!!
—
~A happy Soul~
~A happy Soul~
Complete thread:
- Q1 / Q2 Guidance FDA jag009 2015-05-02 07:27 [Regulatives / Guidelines]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Q1 / Q2: CFR 320 may be of some helpluvblooms 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 help nobody 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 helpluvblooms 2015-05-04 06:55
Ing. Helmut Schütz