Investigational New Drugs

Question 1

IND Regulations

Answer 1

21 CFR 312 cover procedures and requirements for INDs

Regulations also define the roles and responsibilities of FDA reviewers, IND sponsors and clinical investigators

Question 2

Define IND

Answer 2

New drug or biologic used in a clinical investigation

Question 3

IND application

Answer 3

Request to FDA for authorization to administer an investigational drug or biologic to humans
(Notice of Claimed Investigational Exemption for a New Drug)

Question 4

Define Sponsor

Answer 4

Individual, company, academic institution, or other organization that takes responsibility for and initiates a clinical investigation

Question 5

Define Investigator

Answer 5

Individual under whose immediate direction a drug is administered or dispensed

Question 6

Define Sponsor-Investigator

Answer 6

Individual who both initiates and conducts an investigation

Do not include any person other than an individual

Question 7

What is an IND

Answer 7

Drug that provide sufficient data to warrant study in humans
Must be secured prior to interstate shipment and administration of any new drug or biological product that is NOT an approved drug/biologic

Question 8

Primary Objectives in Review

Answer 8

Safety and rights of subjects

Safety and efficacy of drug

Question 9

Who submits INDs

Answer 9

Sponsor
Sponsor-Investigator
Other entities

Question 10

Commercial INDs

Answer 10

Obtain marketing approval

Question 11

Research INDs

Answer 11

Research-driven, no marketing approval

Question 12

Emergency Use INDs

Answer 12

Only with a life-threatening situation that does not allow time for submission and review of IND

Question 13

Exploratory IND

Answer 13

Study is conducted early in Phase 0
Involves limited human exposure
No therapeutic or diagnostic intent
Less preclinical data support needed

Question 14

Treatment IND

Answer 14

Used to make promising new drugs available to desperately ill pts

Question 15

Six exempt criteria

Answer 15

Not designed to support approval of a ned indication or a change in label
If study is not intended to support a significant change in the advertising
If the study does not involve a rounte of admin, dosage level or pt population that increases the risk
Study is conducted in compliance with IRB
Study is conducted in compliance with regulation regarding promotion and charging
It does not intend to invoke 21 CFR 50.24 (exception from informed consent requirements for emergency research)

Question 16

IND Content Requirements

Answer 16

Cover sheet
TofC
Introduction
Investigational Plan
Brochure
Protocols and supporting data
CMC data
Pharmacology and toxicology data
Previous human experience
Additional Information

Question 17

IND Processing

Answer 17

FDA is required by regulation to respond within 30 days
If no issues, IND is considered in effect and sponsor may start the study
If issues cannot be resolved within 30 days, FDA can place the study on clinical hold

Question 18

FDA Review

Answer 18

Safety Medical/clinical
Chemistry/Manufacturing/Control
Pharmacology/Toxicology
Statistical

Question 19

Sponsor Responsibilities

Answer 19

Qualified investigator selection that conduct in accordance with protocols
Properly monitor
Maintain an effective IND
Inform FDA of new AE
Maintain adequate records, reporting and monitoring

Question 20

Investigator Responsibilities

Answer 20

Agrees to personally supervise
Ensure investigation is conducted accordingly
Protects the rights, safety and welfare of study subjects, and obtain their informed consent
Controls investigation drugs
Report AE
Case histories uptodate

Question 21

IND Holder Responsibilites

Answer 21

If an investigator submits an IND, they are responsible for following regulations for both a sponsor and investigator

Question 22

Protocol Amendments

Answer 22

A new protocol
Changes to an existing
New investigator or update
Submitted before implementation and must be approved

Question 23

Information Amendments

Answer 23

Clinical data
Pharmacology or toxicology data
CMC data
Notice of discontinuance of a clinical study

Question 24

Annual Reports

Answer 24

Must be submitted within 60 days of the anniversary date that the IND went into effect
Info included: brief summary, update general investigational plan,