Investigational new drug application

INVESTIGATIONAL NEW DRUG
APPLICATION
(INDA)
KIRSHA K S

An IND is a submission to the Food and Drug Administration
(FDA) requesting permission to initiate a clinical trial.
It can be submitted by the sponsor, but may employ CRO to conduct
the actual studies.
The Appendix I of Schedule Y of Drugs and Cosmetics Rules specifies
the data required to be submitted along with the application to conduct
clinical trial.
The IND application provides the FDA with the data necessary to decide
whether the new drug and the proposed clinical trial pose a
reasonable risk to the human subjects participating in the study.
INDA is reviewed to ensure the protection of rights and safety of the
human subjects and that the investigational plan is sound and allows
evaluation of safety and effectiveness of approval.
KIRSHA K S

IMPORTANCE OF INDA
❖ An INDA is required any time to conduct a clinical trial of an unapproved
drug.
❖ An IND would be required to conduct a clinical trail if the drug is
 A new chemical entity , not approved for the indication under
investigation in a new dosage form.
 Being administered at a new dosage level.
 In combination with another drug and the combination is not
approved.
❖ All clinical studies where a new drug is administered to human subjects,
regardless of whether the drug will be commercially developed , require
an INDA.
KIRSHA K S

An IND is not required to conduct a study if the drug :
 Is not intended for human subjects , but is intended for in vivo
testing or lab research animals (non clinical studies).
 It is an approved drug and the study is within its approved indication for
use.
KIRSHA K S

TYPES OF IND
An Investigator IND
 It is submitted by a physician who both initiates and conducts an
investigation, and under whose immediate direction the investigational drug is
administered or dispensed. A physician might submit a research IND to propose
studying an unapproved drug, or an approved product for a new
indication or in a new patient population.
Emergency Use IND
 It allows the FDA to authorize, use of an experimental drug in an
emergency situation that does not allow time for submission of an IND in
accordance with 21CFR , Sec. 312.23 or Sec. 312.20. It is also used for patients
who do not meet the criteria of an existing study protocol, or if an
approved study protocol does not exist.
Treatment IND
 It is submitted for experimental drugs showing promise in clinical testing
for serious or immediately life-threatening conditions while the final
clinical work is conducted and the FDA review takes place. KIRSHA K S

CLASSIFICATION OF INDA
Commercial
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 which has not planned to market the
product
KIRSHA K S

INDA requires information in three broad areas:
1.Animal Pharmacology andToxicology 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 (often foreign use).
2. 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 to ensure that the company can adequately
produce and supply consistent batches of the drug.
KIRSHA K S

3. Clinical protocols and investigator information
 Detailed protocols for proposed clinical studies to assess whether the initial-
phase trials will expose subjects to unnecessary risks.
 Information on the qualifications of clinical investigators--professionals
(generally physicians) who oversee the administration of the experimental
compound--to assess whether they are qualified to fulfill their clinical
trial duties.
 Finally, 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
Once the INDA is submitted, the sponsor must wait 30 calendar days
before initiating any clinical trials.
During this time, FDA has an opportunity to review the INDA for safety to assure
that research subjects will not be subjected to unreasonable risk.
KIRSHA K S

US FDA REQUIREMENTS (CONTENTS OF INDA)
1. Name, address, and telephone number of the sponsor of the drug.
2. Name and titles of the person responsible for monitoring the conduct and
progress of the investigation.
3. Name and titles of the persons responsible for the review and evaluation
of information relevant to safety of the drug.
4. Name and address of any CRO involved in the study.
5. Identification of phase or phases of clinical investigation to be conducted.
6. Introductory statement and general investigational plan.
7. Description of the investigational plan.
8. Brief summary of previous human experience with the drug, including the
reasons if the drug has been withdrawn from any other investigation and/
or marketing.
KIRSHA K S

9. Chemistry, manufacturing and control information.
10. Pharmacologic and toxicology information.
11. If the new drug is the combination of previously investigated
components, a complete preclinical and clinical summary of these
components when administered singly and any data or expectations
relating to the effect when combined.
12. Clinical protocol of each planned study.
13. Commitment that an Institutional Review Board has approved the
clinical study and will continue to review and monitor the investigation.
14. Investigator Brochure.
15. Commitment not to begin clinical investigation until the INDA is
approved, signature of the sponsor or authorized representative, and the
date of signed application.
KIRSHA K S

PRE-INDA CONSULTATION PROGRAM
CDER's Pre-Investigational New Drug Application (INDA) Consultation
Program fosters early communications between sponsors and new
drug review divisions to provide guidance on the data necessary
to warrant IND submission.
The review divisions are organized generally along therapeutic class and can
each be contacted using the designated Pre-IND Consultation List.
KIRSHA K S

GUIDANCE DOCUMENTS FOR INDs
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.
Because guidances are not regulations or laws, they are not enforceable, either through
administrative actions or through the courts. An alternative approach may be used if it
satisfies the requirements of the applicable statute, regulations, or both.
KIRSHA K S

CODE OF FEDERAL REGULATIONS (CFR)
The final regulations published in the Federal Register (daily
published record of proposed rules, final rules, meeting notices, etc.) are
collected in the Code of Federal Regulations (CFR) .
KIRSHA K S

21CFR Part 312 Investigational New Drug Application
21CFR Part 314 INDA and NDA Applications for FDA Approval to
Market a New Drug (New Drug Approval)
21CFR Part 316 Orphan Drugs
21CFR Part 58 Good Lab Practice for Nonclinical Laboratory
[Animal] Studies
21CFR Part 50 Protection of Human Subjects
21CFR Part 56 Institutional Review Boards
21CFR Part 201 Drug Labeling
21CFR Part 54 Financial Disclosure by Clinical Investigators
KIRSHA K S

MANUAL OF POLICIES AND PROCEDURES (MaPPs)
CDER's Manual of Policies and Procedures (MaPPs) are approved
instructions for internal practices and procedures followed by
CDER staff to help standardize the new drug review process and
other activities.
All MAPPs are available for the public to review for a better understanding of
office policies, definitions, staff responsibilities and procedures.
KIRSHA K S

• Once the IND is stamped as received, it is sent to the review division within
CDER.
• On arrival at the review division, it is critically evaluated by several reviewers
of
o Chemistry
o Biopharmaceutics
o Medical
o Statistics
o Microbiology
o Pharmacology /toxicology sections
 All these areas review the data submitted with the primary purpose to ensure
safety of the individual enrolled in the study.
Once an IND is submitted, the study can’t be initiated until a period of 30
days. If there are any major issues relating to the safety of the volunteers in
the proposed study, the FDA can institute a clinical hold
KIRSHA K S
INDA REVIEW PROCESS

Sponsors should submit an annual report that provides the FDA
with a brief update on the progress of all investigations included
in the IND.
It should contain the following:
 Individual study information.
 Summary of the study.
 Listing of any significant foreign marketing developments with the drug
e.g. approval in another country
KIRSHA K S

Investigational new drug application

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