Investigational New Drug Decisions in IRB Review

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Investigational New Drug Decisions in IRB Review

• Jim Ruble, PharmD, JD
• Manager, Infusion Services
• Pharmacy Department
• jim.ruble_at_hsc.utah.edu

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Outline

• Basic IND Information
• Investigator and IND Determination
• IRB Panel Review and IND Determination

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INDA Basics

• Govt license allowing study sponsors and
  investigators to ship drugs across state lines
• interstate commerce license
• Sometimes called, IND Exemption
• New Drugs require approval for marketing (i.e.,
  FDA Approval) before they are allowed to cross
  state lines
• INDA is intended to inform the FDA as to the
  clinical plan for investigating safety and
  efficacy for a new drug

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INDA Laws and Regulations
The Congress shall have power to regulate
commerce with foreign nations, and among the
several states
Constitution
Art 1, 8
US Code
21 USC 355 - New Drugs 21 USC 355(h)
Code of Federal Regulations
21 CFR 312 and 314 Investigational New Drug
Applications
Agency Policies and Procedures
FDA/CDER MaPP 6030.1 processing and review
of INDA
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Drug Development Map
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INDA Statistics
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INDA Contents

• Three broad areas of information required
• Animal Pharmacology and Toxicology Studies
• Manufacturing Information
• Clinical Protocols and Investigator Information

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INDA Contents

• IND Parts
• FDA Form 1571 1572
• Table of Contents
• Introductory Statement
• General Investigational Plan
• Investigators Brochure
• Protocols (study, investigator, facilities, IRB)
• Chemistry, manufacturing, control data and EIS
• Pharmacology/Tox data
• Previous human experience
• Additional information

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Procedure for submitting INDA

• Screening laboratory work
• Pre-IND conference with FDA may be utilized
• Sponsor/investigator completes FDA Forms 1571
  1572 for submission in connection with INDA
• Once the IND is submitted
• Sponsor must wait 30 days prior to shipping drug
  in interstate commerce
• Ship study drug and conduct research
• phases I-III
• Submit NDA

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IND Categories

• Commercial
• Sponsor initiated
• Research (Non-Commercial)
• Investigator IND
• Sponsor/investigator initiated
• Emergency Use IND
• FDA authorized use of study drug in emergency
  situation which does not allow for submission of
  an IND
• Treatment IND
• Allows more availability in patients with
  serious/Life-threatening conditions while final
  clinical work and review are completed

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INDA exemptions

• INDA NOT required if (must meet all 6)
• Use not intended to support FDA review of a new
  indication
• Use not intended to support significant change in
  advertising
• Use does not involve admin route, dose, use in
  subject pop, or other factor that significantly
  increases risk associated with drug
• Use complies with IRB and Informed consent
  requirements
• Use complies with drug promotion and sales
  requirements
• Use not intended to invoke 21 CFR 50.24

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IND Determination by Investigator
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IRB Panel Reviewer and IND Determination
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Additional INDA information

• FDA Website
• www.fda.gov/cder/regulatory/applications/ind_page_
  1.htm
• www.fda.gov/cder/mapp.htm
• US Code
• FDCA www.access.gpo.gov/uscode/title21/chapter9_su
  bchapterv_parta_.html
• CFR, Part 21
• www.access.gpo.gov/cgi-bin/cfrassemble.cgi?title2
  00621