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Dr Gupta
In reponse to your question there is specific guideline for
Antidiabetic drugs by EMEA but there is no specific guidelines by
FDA for Antidiabetic drugs. I think, FDA had a meeting in the past
on this issue on March 12, 1998 regarding Guidance Document for the
development of drugs for the treatment of diabetes mellitus but i
think till now they didn't come up with a conclusion as i am also
searching for the specific guidance by FDA for Anti diabetic drugs if
you have resolved your query please forward me up any additional
information on the same.
Thanks and Regards
Anuj Kapoor
Clinical Development
Dr.Reddy's Laborteries
Miyapur
Hyderabad
India
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