FDA Good ANDA submission practices Jan-2018 draft [Regulatives / Guidelines]
Hi!
https://www.fda.gov/ucm/groups/fdagov-public/@fdagov-drugs-gen/documents/document/ucm591134.pdf
Whole Section "VI BE deficiencies"

https://www.fda.gov/ucm/groups/fdagov-public/@fdagov-drugs-gen/documents/document/ucm591134.pdf
Whole Section "VI BE deficiencies"

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Kindest regards, nobody
Kindest regards, nobody
Complete thread:
- FDA Good ANDA submission practices Jan-2018 draftnobody 2018-01-18 15:11 [Regulatives / Guidelines]
- Need to know or nice to know Helmut 2018-01-18 15:36