• 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
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
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
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
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.
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
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