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CDER: 312 Subpart F - Miscellaneous provisions including import & export requirements and foreign clinical studies and issuance of guidance to help comply with regulatory requirements (312.145)
Investigational New Drug Regulations
OMB: 0910-0014
IC ID: 189332
OMB.report
HHS/FDA
OMB 0910-0014
ICR 202403-0910-001
IC 189332
( )
Documents and Forms
Document Name
Document Type
ICH Guidance - Good Clinical Practice March 2018.pdf
Other-Agency Guidance
Information Collection (IC) Details
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