Investigational New Drug Review Process

INVESTIGATIONAL NEW DRUG REVIEW PROCESS

Investigational New Drug Review Process
Prashanth Kumar Ponugoti
Northeastern University

INVESTIGATIONAL NEW DRUG REVIEW PROCESS

Abstract

Investigational New Drug (IND) review process begins from the time the sponsor files investigation new drug application and the purpose of the review is to confirm the safety and efficacy of the patient for the drug. Moreover in the process of review if the review committee notifies any deficiencies by the new drug then there will be a clinical however if there are no deficiencies the drug will be approved for new drug application and will be under continuous review to make sure , that the drug does not cause any potential harm. This entire step wise process of review is explained in the following paper

INVESTIGATIONAL NEW DRUG REVIEW PROCESS

The following flow chart gives an overview of the IND review process
Applicant (Drug Sponsor)

IND

Review by CDER
Statistical
Pharmacology/ Toxicology
Medical
Chemistry

Sponsor Submits New Data
Safety Review

Safety acceptable for study to proceed Clinical Hold Decision

Notify Sponsor

Complete reviews

Reviews Complete and Acceptable?
Sponsor Notified of Deficiencies

No Deficiencies
Study Ongoing

INVESTIGATIONAL NEW DRUG REVIEW PROCESS

I. Applicant (Drug sponsor): An applicant or the sponsor is a person or a group who takes responsibility and initiates for the investigation of new drug. A person other than an individual that uses one or more of its own employees to conduct an investigation that it has initiated is a sponsor. The sponsor may be an individual, partnership, government agency, private agency, or any other organization and moreover the sponsor does not conduct the investigation process unless the sponsor is a sponsor-investigator. The applications are submitted to
Center for Drug Evaluation and Research (CDER)
Food and Drug Administration