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INVESTIGATIONAL NEW DRUG(IND)

NEEL PARMAR

DEPARTMENT OF REGULATORY AFFAIRS, CPS, NORTHEASTERN UNIVERSITY

RGA 6463 REGULATORY STRATEGY FOR PRODUCT DEVELOPMENT

PROF SHRENIK DESAI

10/25/2022

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INTRODUCTION

The USFDA's Investigational New Drug program allows pharmaceutical companies to send an investigational drug across state boundaries before the drug's marketing application has been authorized.
Once an IND application is submitted the sponsors must wait for a period of 30 days to get a green light from FDA to conduct their clinical trials
The FDA evaluates the IND application for safety to ensure that study participants are not put at undue danger. If the application is approved, the medicine will typically undergo phase 1 clinical trials.

CRITERIA FOR AN IND APPLICATION

An IND is required for a clinical study if it is intended to support a

New Indication
Change in the approved route of administration or dosage level
Change in the approved patient population ( e.g., pediatric) or a population at greater risk (elderly, HIV positive)
Significant change in promotion of an approved drug

CLASSIFICATION AND TYPES OF IND APPLICATIONS

IND APPLICATION MUST CONTAIN INFORMATION IN THREE BROAD AREAS

Animal Pharmacology and Toxicology studies

Manufacturing information

Clinical protocols and investigator information

CONTENT OF AN IND

WITHDRAWAL OF AN IND

An effective IND can be withdrawn at any moment by the sponsor. In such a circumstance, the FDA and IRB must be told of the cause for the withdrawal, all clinical trials must be terminated, all present investigators and subjects must be contacted, and any medication stockpiles must be returned or disposed of at the option of the sponsor in accordance with 312.59.

REFERENCES