US FDA Form 1572 [Regulatives / Guidelines]

posted by Ohlbe – France, 2010-05-10 00:37 (5876 d 01:33 ago) – Posting: # 5319
Views: 4,348

Dear Kiran
  1. Is the study conducted under an IND (21 CFR part 312) ? Quite unusual for a BE. If not under an IND, no need for a Form 1572.
  2. Do you work for the sponsor side, or for the investigator side ?
Regards
Ohlbe

Regards
Ohlbe

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