Investigational New Drug

Date of Publication:

2/27/2008

Definition:

A drug or biological product subject to the FDA regulations at Part 312 of Title 21, Code of Federal Regulations, Parts 50, 56, 312, Subpart I of Part 314, Subpart G  of Part 601, as amended, including: A drug not approved or a biological product not licensed by the FDA and a drug unapproved for its applied use.