Download Analysing the Investigational New Drug (IND) Application IND

Analysing the Investigational New Drug (IND) Application
Andrew Willis
A Willis Consulting Services
Email‐[email protected]
IND Application:
About the Regulation
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Provides procedures for use of investigational new drugs
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Exempts products from pre‐marketing approval requirements:
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Registration, listing, interstate distribution
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Labelling
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GMPs
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Applies to most studies to determine drug safety and effectiveness
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When IND Application is Not Required: Clinical Study Situations
Š Drug legally marketed for indicated use
Š Study not intended to support new indication or significant labeling change
Š Study not intended to support significant change in advertising
Š Study doesn’t involve change in route of admin, dosage, or use that significantly increases patient risks
Š IVD biological for confirmatory diagnostic procedure
Š Intended for tests of in vitro or lab research animals
Š Placebo products
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“Treatment” IND:
When Used
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Drug intended to treat or diagnose serious or life‐
threatening condition
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No satisfactory alternative available
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Controlled clinical trials in progress under IND
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Or when trials completed and FDA review of request to market is pending
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Sponsor actively pursuing device marketing approval with FDA
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“Emergency Use” IND:
When Used
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Need FDA authorisation to use experimental drug in an emergency situation that does not allow time for submission of an IND in accordance with 21 CFR Part 312
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May be used for patients ineligible per existing study protocol(s), or if approved study protocol does not exist 4
IND Application: Product Labelling Requirements
Š Immediate package must be labelled:
Š “Caution: New Drug – Limited by Federal (or United States) law to investigational use”
Š No false or misleading statements
Š No representation that drug is safe or effective for indicated use
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IND Application: Promotion & Charging for Investigational Drugs
Š No representation that drug is safe or effective for indicated Use
Š No commercial distribution or test marketing
Š No prolongation of study
Š Prior written approval from FDA required to “charge” for drug, unless being used under “treatment” IND
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IND Application: Clinical Study Phases
Š Phase 1 – first time in human
Š Small number of healthy volunteers
Š Closely monitored – focus on safety
Š Phase 2 – controlled studies to evaluate effectiveness
Š Small number of subjects with condition to be treated
Š Closely monitored – focus on efficacy (& safety)
Š Phase 3 – expanded controlled and uncontrolled studies
Š Large number of subjects with condition to be treated
Š Focus on efficacy (& safety)
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