CBER: Part 312 Subpart A - General Provisions; including applicability of requirements and requests for waivers

Investigational New Drug Regulations

OMB: 0910-0014

IC ID: 5669

Documents and Forms

Document Name Document Type
Form Form FDA 1572 CBER: Part 312 Subpart A - General Provisions; including applicability of requirements and requests for waivers Form
Form FDA 1572 Statement of Investigator FORM FDA 1572 Statement of Investigator.pdf Form
FDA 1571 Investigator e-Form screenshots 0014 Getting Started Page PRA Statement.pdf Form and Instruction
FDA 1571 Investigational New Drug Application FDA-1571 updates.pdf Form
FDA-form-1571_r13_instructions_508_FINAL_CDERProposedEdits.pdf Instruction