Biowaivers application [Regulatives / Guidelines]

posted by vishal vayeda  – 2008-10-23 16:40 (6459 d 16:14 ago) – Posting: # 2577
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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

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