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Investigational New Drug (IND) Binder Instructions September 15, 2016, Instructions This binder is available to help study sites achieve and maintain regulatory compliance when submitting to the Food

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What is investigational new drug (IND)?

IND is a submission to the FDA that allows a drug to be tested in humans.

Who is required to file investigational new drug (IND)?

Any person or entity conducting clinical trials on a new drug must file an IND.

How to fill out investigational new drug (IND)?

An IND application includes information on the drug's chemistry, manufacturing, pharmacology, toxicology, and human testing plans.

What is the purpose of investigational new drug (IND)?

The purpose of an IND is to ensure the safety and rights of human subjects in clinical trials and to provide information to the FDA to support the approval of a new drug.

What information must be reported on investigational new drug (IND)?

Information on the drug's composition, manufacturing process, preclinical study data, proposed clinical trial protocol, and investigator qualifications must be reported on an IND.

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