Different sources of Prescribing Information [Regulatives / Guidelines]

posted by Ohlbe – France, 2018-03-21 18:14 (1352 d 22:53 ago) – Posting: # 18577
Views: 2,126

Dear Siddheshwar,

» Two different sources available for Prescribing Information (PI).

Oh, there are actually much more than 2, if you also look outside of the USA...

» Among these sources, which source of Prescribing Information being used during conduct of clinical study considering the safety and other concerns.

Well, use for what purpose ?

When you prepare the information form for the subjects: I would suggest you to also look at the information approved in India, not just in the USA, Europe or wherever... Use the most complete list to inform the subjects. You may actually combine information from several official sources to prepare your information form and make it as complete and comprehensive as possible. Keep all documents used as source in the TMF.

To determine whether SAEs are expected or not (and therefore could be a SUSAR requiring expedited reporting), if you are the sponsor or if the sponsor delegated this task to you: only approved information should be used, not information submitted but not yet approved. But if you run your trial in India, wouldn't the CDSCO expect you to use the information they have approved, rather than the FDA's ?


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