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 obtain 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 of 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 organization 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 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) Modul ule 1 1 –Regio ional A Adm dmin Clinical s supply L Labels Ge General I l Investig igational P l Plan Investigato tor B Brochure Sum ummary o of CM CMC Summary o of toxic icolo logy studie ies Modul ule 2 2- Summa mmaries Summary o of pharmacolo logy , , Pharmacokin inetic ic studie ies Summary o of clin inic ical s l studie ies i if availa ilable le CM CMC o on n Drug S Sub ubstance Modul ule 3 3- CMC CMC MC o on Drug P g Product Pharmacolo logy T Toxicolo logy I Informatio ion Modul ule 4 4- Nonc ncli linical R l Repo ports Nonclin linic ical R l Reports Protocol FDA F Form 1572 1572 Modul ule 5 5- Cli linical S Studies Investiga gator C CV Clinic ical r reports o of 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 on 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 or Bioequiv ivale lence St Studie ies i in H Humans i if t they m y meet a all the f foll ollowin 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
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