Sponsor-Investigator

IND Application Submission

Cross-reference Information

New IND applications may rely on previously submitted information regarding the drug when authorized by the original submitting party (often a pharmaceutical company).This process is referred to as a “cross-reference”. FDA regulations provide that with authorization, information previously submitted to the FDA regarding chemistry, manufacturing, and control (CMC), as well as information regarding pharmacology and toxicity, may be incorporated by reference into a new IND submission.

21 CFR 312.23 (b)

Instructions:

(See acronyms below)

  1. Request a “Letter of Authorization” (LOA) in order to use previously submitted information from the original submitter (e.g. the pharmaceutical company that has filed a prior IND or NDA on the drug for which you will be requesting an IND).
  2. The LOA must come from the sponsor/holder/ Responsible Official of the IND, NDA or DMF referenced and must identify the file by name and IND number, be signed by the sponsor of the cross-referenced file and explicitly give FDA permission to reference that information submitted previously. See sample LOA text below.
  3. Attach the LOA in the IND submission in the section for Additional Information
  4. If you are requesting use of information from a cross-referenced file regarding CMC, include the following statement in your submission, “Refer to previously submitted information (see attached cross-reference authorization letter)”

Be sure to include the LOA that permits the FDA to access the manufacturer’s IND, NDAor Drug Master File (DMF) for this CMC information.

  • If requesting use of information from a cross-referenced file for pharmacology and toxicology information, include the following statement in the submission “Refer to previously submitted information (see attached cross-reference authorization letter)” and attach the LOA that permits the FDA to access the manufacturer’s IND, NDA or DMF for this pharmacology and toxicology information.

LOASample text:

(Sponsor or company name) hereby authorizes the Food and Drug Administration to reference IND (number) for ( name of drug) in support of an IND applicationto be requested by (name of sponsor-investigator) to conduct the following protocol (protocol title)in support of their IND application.

This letter will apply for all relevant (specify: clinical, preclinical toxicology and pharmacology information, as well as chemistry, manufacturing and controls) information submitted in our IND.

CMC:Chemistry, Manufacturing, and Control

IND:Investigational New Drug

LOA:Letter of Authorization

NDA:New Drug Application

DMF:Drug Master File

IND submission

Cross-reference information

Version 12/13/2012