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Efficient use of FDA resources can lead to more efficient drug development.  These questions and answers can be especially helpful to small businesses that may have limited experience interacting with the Agency, or are unfamiliar with pre-IND meetings.

What are the definitions of the terms used in these questions and answers?
IND — The IND (investigational new drug application) is the vehicle through which a sponsor advances to the next stage of drug development known as clinical trials (human trials).  Information on the IND application process is available at the IND Applications website.

Active Pharmaceutical Ingredient — Any substance or mixture of substances intended to be used in the manufacture of a drug (medicinal) product and that, when used in the production of a drug becomes an active ingredient of the drug product.

Good Clinical Practice — Good Clinical Practice (GCP) is a standard for the design, conduct, performance, monitoring, auditing, recording, analysis, and reporting of clinical trials.  For more information to the Good Clinical Practice website.

Orphan Drug — The term orphan drug refers to a product that treats a rare disease affecting fewer than 200,000 Americans.  For additional information go to the FDA Orphan Products website.

Fast Track — Fast track programs are designed to facilitate the development and expedite the review of new drugs or biologics that are intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs.  The guidance Fast Track Drug Development Programs - Designation, Development, and Application Review (PDF - 83KB) provides additional information.

Accelerated Approval — Accelerated approval is a program that FDA developed to make new drug products available for life-threatening diseases when they appear to provide a benefit over available therapy (which could mean there was no existing effective treatment).  The guidance Fast Track Drug Development Programs - Designation, Development, and Application Review (PDF - 83KB) provides additional information.