Investigational New Drug Regulations

This information collection supports FDA regulations regarding investigational new drug applications. The IND requirements provide the means by which FDA can: (a) monitor the safety of ongoing clinical investigations; (b) determine whether the clinical testing of a drug should be authorized; (c) ensure production of reliable data on the metabolism and pharmacological action of the drug in humans; (d) obtain timely information on adverse reactions to the drug; (e) obtain information on side effects associated with increasing doses; (f) obtain information on the drug's effectiveness; (g) ensure the design of well-controlled, scientifically valid studies; and (h) obtain other information pertinent to determining whether clinical testing should be continued and information related to the protection of human subjects.

The latest form for Investigational New Drug Regulations expires 2022-03-31 and can be found here.

CBER: Part 312 Subpart A - General Provisions; including applicability of requirements and requests for waivers

Federal Enterprise Architecture: Health - Consumer Health and Safety

Review document collections for all forms, instructions, and supporting documents - including paper/printable forms.