FDA REQUI UIREMENTS FOR OR I IND IN US USA Dr. Suzan Davis - - PowerPoint PPT Presentation

FDA REQUI UIREMENTS FOR OR I IND IN US USA

• Dr. Suzan Davis

February 2020

What i is an an I IND ? ?

Investigational New Drug (IND) is an application that is submitted to US FDA by a pharmaceutical company to

• btain permission from the Agency to start human clinical

trials and ship an experimental drug across different states in United States of America.

What a are t e the T e Types es o

• f INDs ?

?

 Comme

mmercial I IND is submitted by a sponsor that is usually a corporation, with the intend to commercialize the product at a later date.

 Resea

earch I h IND is submitted by an Individual Investigator or research

• rganization that conducts the investigation for research purpose.

 Expended A

pended Access I IND is submitted to allow patients to use the investigational drug for the treatment of serious or life-threatening conditions with no comparable alternative treatment, outside the formal clinical trial.

What a are t e the I e IND P Phas ases es ? ?

• An IND may be submitted for one or

more phases of an investigation.

• The clinical investigation of a

previously untested drug is generally divided into the following three phases:

• Phase 1: safety, proof of concept,

and exploratory.

• Phase 2: safety, efficacy, and

dose ranging.

• Phase 3: efficacy confirmatory,

dose ranging, and safety.

What i is the I IND Content?

• The IND needs to be

submitted in electronically and in eCTD format.

• The IND needs to include

Module 1, Module 2,Module 3, Module 4 and Module 5.

What i is the I IND Content?

CTD M Module ules Descriptio ion Modul ule 1 1 –Regio ional A Adm dmin

• Cover l

letter tter

• Table o

e of conten ents

• FDA 1571

1571 (cover s sheet), FDA 3674 3674 (clin inic ical l tria ials ls C Certif ific icatio ion)

• Clinical s

supply L Labels

• Ge

General I l Investig igational P l Plan

• Investigato

tor B Brochure

Modul ule 2 2- Summa mmaries

• Sum

ummary o

• f CM

CMC

• Summary o
• f toxic

icolo logy studie ies

• Summary o
• f pharmacolo

logy , , Pharmacokin inetic ic studie ies

• Summary o
• f clin

inic ical s l studie ies i if availa ilable le

Modul ule 3 3- CMC

• CM

CMC o

• n

n Drug S Sub ubstance

• CMC

MC o

• n Drug P

g Product

Modul ule 4 4- Nonc ncli linical R l Repo ports

• Pharmacolo

logy T Toxicolo logy I Informatio ion

• Nonclin

linic ical R l Reports

Modul ule 5 5- Cli linical S Studies

• Protocol
• FDA F

Form 1572 1572

• Investiga

gator C CV

• Clinic

ical r reports o

• f Previo

ious h human studie ies if availa lable le

FDA T Tim imeli lines f for IN IND R Revie iew?

 Upon receipt of an IND application, FDA will notify the sponsor of the

date it receives the application through an IND acknowledgment letter.

 An IND application may go into effect:

• 30 da

30 days after FDA receives the application, unless FDA notifies the sponsor that the investigations described in the application are subject to a Clinical Hold; or

• on earlier notification by FDA that the clinical investigations in the

IND may begin.

When en F FDA p puts Clinical Ho Hold o

• n IND?

FDA can put a clinical hold on IND when:

• No CMC information is submitted in the IND
• No CMC information is incorporated by reference within

submission

• IND contains insufficient information as required under 21 CFR

312.23 to assess the risks to subjects of the proposed studies.

When en F FDA T Terminates es a an I IND ? ?

FDA can terminate an IND under 21 CFR 312.44 in the following conditions:

• Lack of the requisite CMC information.
• The process of manufacturing/processing is inadequate to maintain

standards and ensure subject safety.

Note : In general FDA will not terminate an IND until after first attempting to resolve the issues.

What S Studies es a are e e exem empt f from I IND?

• 1. Clini

nical s studi udies es conduc ducted w ed with h a marketed d ed drug are e exempt f from IND requi uirem emen ents i if they ey m meet et a all t the f following ng c criteria:

• The drug product is lawfully marketed in the United States.
• The investigation is not intended to support a new indication or significant change

in the labeling or in the advertising for the drug.

• The investigation does not involve a route of administration, dose, patient

population, or other factor that significantly increases the risk (or decreases the acceptability of the risk) associated with the use of the drug product.

• The investigation is conducted in compliance with the requirements for review by

an IRB (21 CFR part 56) and with the requirements for informed consent (21 CFR part 50).

What S Studies es a are e e exem empt f from I IND?

• 2. Bioavaila

ilability ility or

• r Bioequiv

ivale lence St Studie ies i in H Humans i if t they m y meet a all the f foll

• llowin

ing c crit iteria ia:

• The drug product does not contain a new chemical entity, is not

radioactively labeled, and is not cytotoxic.

• The dose (single dose or total daily dose) does not exceed the dose

specified in the labeling of the approved version of the drug product.

• The investigation is conducted in compliance with the requirements for

review by an IRB and with the requirements for informed consent

• The sponsor meets the requirements for retention of test article samples

and safety reporting .

Are c e cGMP R P Required f for I IND ? ?

In July 2008 the FDA issued a guidance which details the cGMP expectations for the early stages of drug development

 Investigational drugs used in Phase 1 studies are exempt from the

cGMP requirements.

 Investigational drug used in Phase 2 or Phase 3 studies must

comply with cGMP.

Refer eren ences

 https://www.fda.gov/regulatory-information/search-fda-guidance-

documents/exploratory-ind-studies

 https://www.fda.gov/regulatory-information/search-fda-guidance-

documents/content-and-format-investigational-new-drug- applications-inds-phase-1-studies-drugs-including-well

 https://www.fda.gov/regulatory-information/search-fda-guidance-

documents/inds-phase-2-and-phase-3-studies-chemistry- manufacturing-and-controls-information

Than ank y you

For additional information please contact us at:

Global Regulatory Partners, Inc. 400 Fifth Avenue, Suite 115, Waltham, Massachusetts, 02451, USA Phone 781-672-4200 Email: info@globalregulatorypartners.com