2. DEFINITION
Investigational New Drug (IND) program is the
means by which a pharmaceutical company obtains
permission to start human clinical trials and to ship
an experimental drug across state lines (usually to
clinical investigators) before a marketing application
for the drug has been approved.
The IND is the means through which the sponsor
technically obtains this exemption from the FDA.
Current Federal law requires that a drug be the
subject of an approved marketing applicationbefore it
is transported or distributed across state lines.
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3.
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When INDA Required?
INDA is required if any pharmaceutical company wants to conduct clinical
trails of an unapproved drug.
INDA would be required to conduct clinical trials if the drug is new
chemical entity, not approved for indication under investigation new
dosage form.
In combination with another drug which is not approved
All clinical studies where new drugs are administered to human subjects,
regardless he whether the drug is commercially developed, require an
IND.
5. TYPES OF
IND
INVESTIGATOR IND
Submitted by physician who both initiates
and conducts the study including the
immediate supervision of the use of the
study drug.
EMERGENCY USE IND
FDA allow to authorise the new
experimental drug in an emergency
situation
That doesn't allow time for submission of
IND
TREATMENT IND
Submitted for experimental drug showing
promise inclinical testing for serious
conditions.
Final clinical work and review conducted by
FDA
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6. CLASSIFICATION OF
IND
Commercial
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• Permits sponsor to collect data on clinical safety and
effectiveness needed for application for marketing in the form
of NDA
Research (non-commercial)
• Permits the sponsor to use drug in research to
obtain advanced scientific knowledge of new drug.
• No plan to market the product.
7. CONTENTS OF
INDA
Animal Pharmacology & Toxicology
Studies
Preclinical data to permit an assessment as to
whether the product is reasonably safe for initial
testing in humans. Also included are any previous
experience with the drug in humans.
Manufacturing Information
Information pertaining to the composition,
manufacturer, stability, and controls used for
manufacturing the drug substance and the drug
product. This information is assessed cure that the
company can adequately produce and supply
consistent batches of the drug.
Clinical Protocols and Investigator
Information
Commitments to obtain informed consent from the
research subjects, to obtain review of the study by
an institutional review board (IRB), and to adhere to
the investigational new drug regulations.
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8. FORMAT OF INDA
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A. Cover sheet (Form FDA-1571)
Name, address, telephone of sponsor
Identification of phases
Commitment not to begin CT until IND approval
Commitment by IRB-Form 56Commitment for conducting CT-
accordance with regulations
Name, title-Monitor
Name, title-person(s) for reviewing
Name, Address of CRO, if any
Signature of sponsor
B. Table of contents
C. Introductory statement & general investigational plan
D. Investigators brochure
E. Study protocol
F. Investigator facilities & IRB data
G. Chemistry manufacturing & control data
H. Pharmacology & toxicology data Previous human experience
9. RESOURCES FOR IND APPLICATION
Pre-IND consultation program: offered by
CDER(center for drug evaluation and
research)
Guidance documents for IND’S
Laws, regulations, policies & procedures
Code of federal regulations (CFR)
Manual policies & procedures
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10. GUIDANCE DOCUMENTS FOR INDS
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Guidance documents represent the Agency's current thinking on a
particular subject.
These documents provide FDA review staff and
applicants/sponsors with guidelines to the processing, content,
and evaluation/approval of applications and also to the design,
production, manufacturing, and testing of regulated products.
They also establish policies intended to achieve consistency in
the Agency's regulatory approach and establish inspection and
enforcement procedures.
