Biowaivers application [Regulatives / Guidelines]
Dear Members,
What is the procedure to get the biowaivers as per the classifcation of BCS drugs in the US guideline (Guideline for bio waivers) and which kind of data are needs to be submitted for the same.
If there is any specific application form is available then please let me know the reference.
Regards,
Vishal Vayeda
What is the procedure to get the biowaivers as per the classifcation of BCS drugs in the US guideline (Guideline for bio waivers) and which kind of data are needs to be submitted for the same.
If there is any specific application form is available then please let me know the reference.
Regards,
Vishal Vayeda
Complete thread:
- Biowaivers applicationvishal vayeda 2008-10-23 14:40
- Biowaivers application santosh.awale 2009-01-19 12:39
