IND is not required:

• In case the drug is not intended for human subjects.

• In case the drug is intended for in vivo testing.

• When the drug is already approved and study is conducted within the approved

indication for use.

INVESTIGATOR'S BROCHURE (IB)

It is a compilation of the clinical and non-clinical data on the investigational product

that is relevant to the study of the product in human subjects. The main purpose of an

investigator's brochure is to provide information to the investigator. It also enables

the investigator to understand the trial and make benefit/risk assessment of the

investigational product by own. The investigational brochure is edited by a medically

qualified person.

NEW DRUG APPLICATION (NDA)

The application through which drug sponsors propose the approval of a new drug

product; for marketing in front of regulatory authority. It includes all clinical and

non-clinical data.

Review time frame: The FDA will review and issue an approval, approvable,

or non-approvable letter within 180 days of receipt of application. This period is

known as review-clock. In this period the application is reviewed by the FDA

thoroughly. During this period applicant may withdraw the application and resubmit

it later.

Filing time frame: After 60 days of receiving the application, the FDA will decide

whether the application may be filed or not. If the FDA filed the application, then

applicants will be notified otherwise the applicant will be allowed to discuss the reason

for non-filing of application with FDA.

CLINICAL RESEARCH/BE STUDIES

BE stands for bioequivalence. It is a relative term. It denotes that a drug substance in

two or more identical dosage forms reaches the systemic circulation at the same relative

rate and to the same relative extent.

Summary 147