Hi Rising, these are the FDA regs re PCH response. "If the...

Hi Rising, these are the FDA regs re PCH response.

"If the sponsor addresses all of the clinical hold issues identified in the Agency's clinical hold letter (acomplete response), the Agency must respond to the sponsor within 30 days of receipt of the complete response (§ 312.42(e)). The 30-day response clock does not begin until a complete response to the clinical hold is received by the Agency."
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"What happens if I think my response is complete, but the FDA disagrees?
If FDA finds that your response is not complete, FDA will notify you as soon as possible by phone or other means of rapid communication, but no later than 30 days after receipt of your response. The Agency will tell you what information is needed to make it a complete response. The 30-day clock will not start until the FDA receives what it believes to be a complete response to the clinical hold letter."
http://www.fda.gov/RegulatoryInformation/Guidances/ucm127537.htm