Investigational New Drug Application

?
  • Created by: LBCW0502
  • Created on: 28-01-20 09:34
Outline the drug discovery process
Pre-discovery (drug discovery, preclinical), IND submitted, clinical trials (phases I/II/III), FDA review, FDA approval, phase IV (post-marketing surveillance)
1 of 44
What is an IND?
Investigational New Drug - a new drug or biologic used in a clinical investigation
2 of 44
What is an IND application?
A request to FDA for authorisation to administer an investigational drug or biologic to humans (Notice of Claimed Investigational Exemption of New Drug)
3 of 44
What is a sponsor?
An individual, company, academic institution or other organisation that takes responsibility for and initiates a clinical investigation
4 of 44
What is an investigator?
An individual under whose immediate direction a drug is administered or dispensed
5 of 44
What is a sponsor-investigator?
An individual who both initiates and conducts an investigation. The term doesn't include any person other than an individual
6 of 44
Describe features of an IND (1)
After preclinical studies provide sufficient data to warrant study in humans, an IND is submitted to the FDA. The IND is a request for authorisation from FDA to administer an investigational drug or biological product to humans
7 of 44
Describe features of an IND (2)
Such authorisation must be secured prior to interstate shipment and administration of any new drug or biological product that is not an approved drug or biologic
8 of 44
Describe features of IND regulations (1)
The regulations in CFR 21 cover procedures and requirements for Investigational New Drug Applications (INDs). Regulations also define roles and responsibilities of FDA reviewers and IND sponsors and clinical investigators
9 of 44
Describe features of IND regulations (2)
(CFR - Code of Federal Regulations document - for more information)
10 of 44
What are the primary objectives?
In all phases of the investigation, the objective is to assure the safety and rights of subjects. In phases II/III, the objective is to help assure the scientific quality for evaluation of drug's safety and effectiveness
11 of 44
Describe the requirements for the submission of an IND
A sponsor (e.g. pharmaceutical or biological company). A sponsor-investigator (e.g. investigator initiated IND). Other entities that want to conduct clinical research with an investigational product (e.g. Foundations, Government agencies)
12 of 44
Outline the IND format (1)
Cover sheet (and form FDA 1571). Table of contents. Introductory statement and general investigation. Investigator's brochure (plan). Clinical protocol. Chemistry, manufacturing and control (CMC) information. Pharmacology and toxicology information
13 of 44
Outline the IND format (2)
Previous human experience. Additional information
14 of 44
Describe features of the IND filing process (1)
FDA required by regulation to respond within 30 days of filing of an initial IND. If no issues identified, the IND is considered to be in effect (approved) and the sponsor may start the study
15 of 44
Describe features of the IND filing process (2)
If issues cannot be resolved within this 30 day period, the FDA can place the study on clinical hold
16 of 44
What does the FDA review process include?
Safety, medical/clinical, chemistry, pharmacology/toxicology, statistical
17 of 44
What are the IND categories? (1)
Commercial (ultimate goal is to obtain marketing approval and is typically 5+ volumes for a phase 1 IND, e.g. submission by a pharmaceutical company). Research/non-commercial (primarily research driven, not marking approval
18 of 44
What are the IND categories? (2)
IND can be a single volume if preclinical and manufacturing information can be cross-referenced to a prior IND e.g. IND submission by Duke Physician
19 of 44
What are the other types of INDs? (1)
Emergency use (for life-threatening situations that doesn't allow time for submission/review of an IND, need submission as soon as possible)
20 of 44
What are the other types of INDs? (2)
Exploratory IND (study conducted early in phase I, involves limited human exposure/non-pharmacologically active doses, not therapeutic effect/diagnostic intent, requires less preclinical data to support study)
21 of 44
What are the other types of INDs? (3)
Treatment IND (used to make promising new drugs available to desperately ill patients as early in the drug development process as possible, patients not eligible to be in the definitive clinical trials which must be well underway, almost finished)
22 of 44
When is a study exempt from an IND? (1)
All six criteria must be met for a study to be considered exempt from requiring an IND
23 of 44
When is a study exempt from an IND? (2)
If the study is not designed to support approval of new indication/change in label. If study is not intended to support significant change in advertising for product
24 of 44
When is a study exempt from an IND? (3)
If study doesn't involved a ROA/dosage level/patient population with significant risks (or decreases acceptability risks) associated with use of drug. Study is conducted in compliance with IRB and informed consent regulations
25 of 44
When is a study exempt from an IND? (4)
Study conducted in compliance with regulations regarding promotion and charging for investigational drug. It doesn't intend to invoke 21 CFR 50.24 (exception from informed consent requirements for emergency research)
26 of 44
State features of IND holder reponsibilities
If an investigator submits an IND, they are responsible for following the regulations for both a Sponsor and an Investigator (Sponsor-Investigator)
27 of 44
What is the sponsor's responsibilities? (1)
Select qualified investigators. Ensure that investigation is conducted in accordance with protocols in IND. Ensure proper monitoring of investigation. Maintain effective IND. Promptly inform FDA and all investigators of significant new adverse events
28 of 44
What is the sponsor's responsibilities? (2)
Maintain adequate records, reporting and monitoring of investigation to include product accountability
29 of 44
What are the investigator's responsibilities? (1)
Commitment to item 9 on Form FDA 1572. Agrees to personally supervise investigation. Ensures investigation is conducted according to investigational plan and applicable regulations. Protects rights/safety/welfare of study subjects
30 of 44
What are the investigator's responsibilities? (2)
Obtain their informed consent. Controls investigation drugs. Reports to the sponsor adverse experiences that occur in the course of the investigation. Ensures an IRB will review and approve of clinical investigation
31 of 44
What are the investigator's responsibilities? (3)
Commits to promptly providing the IRB with information on changes and problems involving risks to human subjects. Prepares and maintains adequate and accurate case histories that record all observations and other data pertinent to the investigation
32 of 44
Describe features of IND amendments (1)
IND is a live document which may be in effect for years or decades. INDs are updated via amendments: protocol amendments (21 CFR 312.30), information amendments (21 CFR 312.31), safety reports (21 CFR 312.32), annual reports (21 CFR 312.33)
33 of 44
Describe features of IND amendments (2)
Response to FDA request for information
34 of 44
Describe features of protocol amendments
A new protocol. Changes to an existing protocol. New investigator or updated form 1572. Protocol amendments must be submitted to FDA prior to implementation. IRB approval is required prior to implementation
35 of 44
Describe features of information amendments
Clinical data (not protocol related). Pharmacology or toxicology data. Chemical Manufacturing and Control (CMC) information. Notice of discontinuance of a clinical study
36 of 44
Describe features of IND safety reports (1)
Investigator is required to inform sponsor of any adverse effect that may be caused by the drug. Sponsor shall notify FDA and all participating investigators in written IND safety report of any adverse experience associate with use of drug
37 of 44
Describe features of IND safety reports (2)
Serious or unexpected experiences are recorded and any laboratory tests that suggest a significant risk for human subjects. A written IND safety report must submitted with 15 calendar days of receipt of the information to FDA and all investigators
38 of 44
Describe features of IND safety reports (3)
For an unexpected fatal or life-threatening experience, the sponsor must inform FDA no later than 7 days of receipt of the information
39 of 44
Describe features of annual reports (1)
Must be submitted within 60 days of the anniversary date that the IND went into effect. Information provided should include: brief summary of each study in progress under IND, summary of information obtained during previous year
40 of 44
Describe features of annual reports (2)
Most AEs by body system, IND safety reports, deaths, drop-outs, list of preclinical studies, CMC or microbiological changes. Updated general investigational plan for coming year
41 of 44
Summarise the IND process and interaction with FDA (1)
Basic research (industry - FDA interactions during development). Prototype design or discovery. Preclinical development (Pre-IND meeting, initial IND submissions). Clinical development with phase I (ongoing submission)
42 of 44
Summarise the IND process and interaction with FDA (2)
Phase II (end of phase 2a meeting, end of phase 2 meeting), phase III (pre-biologic license application or new drug application meeting, BLA or NDA application submission). FDA filing/approval and launch preparation (safety update)
43 of 44
Summarise the IND process and interaction with FDA (3)
IND review phase across clinical development (phase I/II/III). Application review phase (during FDA filing approval/launch reparation)
44 of 44

Other cards in this set

Card 2

Front

What is an IND?

Back

Investigational New Drug - a new drug or biologic used in a clinical investigation

Card 3

Front

What is an IND application?

Back

Preview of the front of card 3

Card 4

Front

What is a sponsor?

Back

Preview of the front of card 4

Card 5

Front

What is an investigator?

Back

Preview of the front of card 5
View more cards

Comments

No comments have yet been made

Similar Pharmacy resources:

See all Pharmacy resources »See all Investigational New Drug Application resources »