ProtectionHumanSubjectsSpring2022-CLASS_Four_Part_3_with_notes (1) (3) (2).pdf

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Human Experimentation:
Methodological Issues
Fundamentals
Week 4 - Part 1
Spring 2022
Mary Dronitsky, JD, MBA, MSN

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Week Three – Part Three
Process of Clinical Trials

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Introduction
• FDA regulates drugs, biologics and devices used in the diagnosis,
cure, mitigation, treatment or prevention of disease even if exempt
from IND or IDE requirements in humans and animals
• FDA conducts rigorous review of drugs, biologics and medical devices
for safety and efficacy for an indication prior to granting approval for
marketing
• FDA and Sponsor draft and negotiate the package insert/approved
labeling before product is marketed
• Approved labeling summarizes what FDA has determined to be safe
and effective use of the product
FDA regulates drugs, biologics and devices used in the diagnosis, cure,
mitigation, treatment or prevention of disease even if exempt from IND or IDE
requirements in humans and animals.
FDA conducts a rigorous review of drugs, biologics and medical devices for
safety and efficacy for a given indication prior to granting approval for marketing.
FDA and Sponsor draft and negotiate the package insert or approved labeling
before product is marketed.
Summarizes what FDA has determined to be safe and effective use of the
product

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Introduction
◼
Clinical studies conducted according to the approved
labeling exempt from Investigational New Drug (IND)
and Investigation Device Exemption (IDE) regulations
◼
FDA does not exempt these studies from human subject
protection regulations
◼
All research studies with FDA regulated products
involved in human studies require IRB review
Exemption from IND/IDE regulations is not an
exemption from IRB review
Further clinical studies conducted according to the approved labeling are exempt
from Investigational New Drug and Investigation Device Exemption regulations.
IND/IDE
FDA does not exempt these studies from the human subject protection
regulations
All research studies with FDA regulated products that involve human studies
require IRB review
Exemption from IND/IDE regulations is not an exemption from IRB review

Stages of Drug Development
"Science& Research." Industry-FDA Interactions During Drug Development .
U.S. Food and Drug Administration,Mar.2004.Web.14Apr.2012.
<
PathOpportunitiesReports/ucm077262.htm>.
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Stages of Medical Device Development
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Class I -General Controls; Most exempt from premarket submission Example –
Dental Floss
Class II – Special Controls; Premarket Notification[510(k)] Example-
Thermometer
Class III – Premarket Approval; Require Premarket Application[PMA]
Example – Replacement Heart Valves
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Drugs and Biologics INDs
◼
Required for human research with biologics or drugs not
approved by FDA
◼
FDA reviews IND applications and will allow human
exposure only if risks of exposure are reasonable
◼
IND application generally includes:
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Evidence of safety and tolerability in animals
◼
Controlled method of manufacture that assures the
consistency of final drug product
◼
Toxicology studies
◼
Well-developed research plan that minimizes risk for
human volunteers
Required for human research with biologics or drugs not approved by FDA
FDA reviews these applications and will allow human exposure only if it feels
risks of exposure are reasonable
IND application generally includes:
Evidence of safety and tolerability in animals