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Q & A

Head shot of a business man. Question: Can I contact the review division directly for pre-IND consultation?

 

 

Answer: Yes, and some offices and review divisions, such as the Office of Antimicrobial Products (OAP), Division of Transplant and Ophthamology Products (DTOP), and the Division of Anti-Infective Products (DAIP) have established pre-IND processes.

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 Ask the FDA for more information CDER Pre-IND Consultation Program Web site
  CDER Pre-IND Consultation Program Web site
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