Investigational New Drug Review Process

Topics: Clinical trial, Food and Drug Administration, Drug development Pages: 6 (1524 words) Published: April 23, 2013

Investigational New Drug Review Process
Prashanth Kumar Ponugoti
Northeastern University



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


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


Review by CDER
Pharmacology/ Toxicology

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


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
Document and Records Section
5901-B Ammendale Rd.
Beltsville, Md. 20705-1266
II. Investigational New Drug Application: Sponsor thinks about new drug application when he has a successful results in preclinical studies (The studies conducted in animals to find the use of drug in human and ensure safety and efficacy) in other words it is the step taken after the successful preclinical studies to continue further studies that is clinical trial in humans. During the conduct of preclinical trial, step by step information of the process is recorded as data and stored. Thus stored information is helpful in filling an IND. The information is as follows A. Animal Pharmacology and toxicology studies

B. Manufacturing Information
C. Clinical protocols and investigators information
Animal Pharmacology and toxicology studies: The studies conducted in animals to ensure the use of the product is reasonably safe for initial testing in humans.
Manufacturing Humans: This is the information obtained from manufacturing, storage, composition, storage and stability, for manufacturing of drug substance and product. Clinical protocols and investigators information: protocols for proposed clinical studies to assess whether the initial-phase trials will expose subjects to unnecessary risks. Information on the qualifications of clinical investigators—professionals who oversee the administration of the experimental compound--to assess whether they are qualified to fulfill their clinical trial duties.

The IND is not a marketing approval but The IND is the means through which the sponsor officially obtains this exemption from the FDA: however, its main intention is to detail the data that provide documentation that it is indeed reasonable to proceed with certain human trials with the drug. Types of INDs

i. Investigator INDs
ii. Emergency Use INDs and
iii. Treatment IND
After the submission of the IND to the Center for Drug Evaluation and Research (CDER)...
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