Investigational new drug application approval process and IND detailed information//INDA//

1. Submitted by:
Srinu KN
1st M pharmacy
Dept. of Pharmaceutics
Al-Ameen college of pharmacy
Submitted to:
Mrs.Tanushree mam
Dept. of Pharmaceutics

2. What is an IND ?
 IND has been defined under 21CFR 312.3(b) (USFDA) as a
new drug or biological drug that is used in a clinical
investigation.
 An IND application is a submission to the food and drug
administration (FDA) requesting permission to initiate a
clinical study of a new drug product
 The IND application is also the vehicle through which a
sponsor advance to the next stage of drug development
known as clinical trials.
2

3.  An IND is required any time I want 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.
 An combination with another drug and the combination is
not approved.
3

4.  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).
 Is an approved drug and the study is within its approved
indication for use.
4

5.  FDA Form 1571.
 FDA Form 1572.
 FDA Form 3674.
5
FDA Form 1571:
IND initial application are triplicated and
submitted by the form FDA 1571
The purpose of the FDA Form 1571 is to provide the
FDA with information about the drug or biologic, the
planned clinical studies, and the safety and effectiveness
data obtained from previous studies. The sponsor must
complete this form and submit it to the FDA before
conducting any clinical trials.

6. 6
FORM 1572 of FDA:
FDA Form 1572, also known as the Statement of
Investigator,
The purpose of FDA Form 1572 is to provide the FDA with
information about the principal investigator who will be
responsible for conducting the clinical trial.
The FDA Form 1572 includes information about the
principal investigator, such as their name, qualifications,
and experience.
In addition to information about the principal
investigator, the FDA Form 1572 also includes
information about the study site where the clinical
trial will be conducted. This includes the name and
location of the site, as well as the names and
qualifications of any sub-investigators who will be
assisting with the study.

7. 7
FORM 3674 OF FDA:
Form 3674 involves amendment supplements
resubmissions
All clinical investigators must be registered with
FDA for phase 1 study which needs to provide all
the trail information

8. 8

9. 9

10. 10

11. 11
Form 1572 of FDA:

12. 12

13. 13

14. 14

15.  COMMERCIAL IND : goal is to obtain marketing approval
for a new product.
 NON-COMMERCIAL IND : It includes
 INVESTIGATOR IND : In this case ,the physician is both
the sponsor and investigator.
 EMERGENCY IND : FDA authorize immediate dispensing
of a non-approved drug in a life threatening situation when
no standard acceptable therapy is available.
 TREATMENT IND : FDA will permit investigational drug to
be used to treat a serious or life threatening disease or if there
is no comparable alternative drug available.
15

16.  A meeting between the sponsor and the FDA frequently is
useful in resolving questions and issues raised during the
preparation of an IND
 The FDA encourages such meetings to the extent that
 They aid in the solution of scientific problems and
 To the extent that the FDA has available resources.
 Most issues and questions are usually related to the
 Design of animal studies needed to initiate the clinical trials.
 The scope and design of the initial study in humans.
16

17.  Meeting should be scheduled to occur within 60 days of the
FDA’s receipt of the written request for the meeting.
 A briefing document is required at least 4 weeks prior to the
meeting.
 The briefing document should provide summary of the
information related to the product.
17

18.  The content and format of an initial IND is laid out in 21
CFR part 312 .
1. Cover sheet – 312.23(a)(1) FDA form 1571
2. Table of contents – 313.23(a)(2)
3. Introductory statement and general investigational plan –
312.23(a)(3)
4. Investigators brochure – 312.23(a)(5)
5. Clinical protocol – 312.23(a)(6)
6. Chemistry , manufacturing and control data – 312.23(a)(7)
18

19. 7. Pharmacological and toxicological information – 312.23(a)(18)
8. Previous human exposure – 312.23(a)(9)
9. Additional information – 312.23(a)(10)
10. Relevant information – 312.23(a)(11)
19

20. 1.Name of the sponsor :
 He is the person who takes responsibility for and initiates a
clinical investigation.
 May be a pharmaceutical company, a private or academic
organization, or an individual.
2.Date of submission :
 It is the date when the application is mailed to FDA.
3. Address :
 It is the address to which written correspondence from FDA
should be directed.
20

21. 4. Telephone number :
 It is the number where the sponsor is usually available
during normal working hours. A telephone number must
be provided.
5. Name(s) of Drug :
 List the generic name(s) and trade name, if available. Also,
state the dosage form(s).
21

22. 6. IND Number :
 If an emergency IND number was previously assigned by
FDA, or the Form FDA 1571 is being included with an
amendment to the original IND, then that IND number
should be entered here; otherwise, the space should be left
blank.
7. Indication
8. Phase of clinical investigation to be conducted
9. list no.of all investigational new drug application
22

23. 10. Serial no.
11. Contents of application
12.Name and title of the person responsible for
monitoring the conduct and progress of clinical
investigation
13. Is any part of the clinical study to be conducted by
CRO
13. Name and title of the person responsible for review
and evaluation of information relevant to the safety of
drug
14. Name of sponsor’s authorised representative
15.Signature
16.Address
17.Telephone no.
18.Date
23

24.  Description of the investigational drug
 All active ingredients
 Drug’s pharmacological classification
 Structural formula
 Route of administration
 Summary of previous human experience
 Formulation of dosage forms
 Objective and planned duration of proposed clinical
investigation.
24

25.  Description of clinical studies planned for the experimental
drug
 Purpose of the study
 Indication to be studied
 Types of trials to be initiated
 Number of study subjects
 Risks involved
25

26.  Structural formula of drug.
 Summary of pharmacological , toxicological ,
pharmacokinetic effects in animals.
 Safety and efficacy
 Purpose of study
 Dose / dose frequency
 Monitoring procedures
26

27.  A clinical protocol describes how a particular clinical trial is
to be conducted
 It describes
 The objectives of study
 The trial design
 How subjects are selected
 How the trial is to be carried out
27

28.  It should contain the following elements:
 A statement of the objective and purpose of study.
 Name , address and qualification of each investigator
participating in the study.
 Name and address of each clinical site.
 Study subject inclusion and exclusion criteria.
 Estimate of the number of subjects to be enrolled in the
study.
28

29.  Determines the adequacy of methods used to manufacture
and assay investigational compound
 Safety concerns
 Describe drug substances
 Method of preparation
 Reagent and solvents
 Acceptable limits and analytical methods to ensure quality
and purity of drug.
29

30.  Pharmacology and drug disposition
 Integrated toxicology summary
Previous human exposure :
 Marketed (foreign) or previously tested in humans.
30

31.  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
 Chemistry
 Biopharmaceutics
 Medical
 Statistics
 Microbiology
 Pharmacology /toxicology sections
31

32.  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 initiate a
clinical hold.
32

33.  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.
33

34. 34