T/R potency <5% [Regulatives / Guidelines]
❝ It was there in 2001 guidance as desired requirement-not mandatory... problem is that I can not find that 2001 (first) BE/BA guidance
❝ I can not find that 2001 (first) BE/BA guidance. Also in 2021 guidance lines 807-808
Correct the "should be within 5%" does exist in the FDA guidance (not the BE guidance for individual products). I was asked to provide the info last yr in a meeting...
John
Complete thread:
- T/R potency <5% Achievwin 2022-09-07 18:22 [Regulatives / Guidelines]
- T/R potency <5% Helmut 2022-09-07 18:55
- T/R potency <5% Achievwin 2022-09-07 20:50
- T/R potency <5%jag009 2022-09-08 19:54
- T/R potency <5% dshah 2022-09-09 10:48
- T/R potency <5% Helmut 2022-09-09 12:13
- T/R potency <5% Achievwin 2022-09-09 14:56
- T/R potency <5% Helmut 2022-09-09 17:08
- T/R potency <5% dshah 2022-09-09 17:42
- T/R potency <5% Achievwin 2022-09-07 20:50
- T/R potency <5% Helmut 2022-09-07 18:55