Guidance for Industry
Q & A
Content and Format of INDs for Phase 1 Studies of Drugs, Including Well-Characterized,
Therapeutic, Biotechnology-Derived Product
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U.S. Department of Health and Human Services
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Center for Biologics Evaluation and Research (CBER)
October 2000
Pharmacology / Toxicology
GUIDANCE FOR INDUSTRY1
Q & A
Content and Format of INDs for Phase 1 Studies of Drugs, Including Well-Characterized,
Therapeutic, Biotechnology-Derived Products
| This guidance represents the Food and Drug Administration's current thinking on this topic. It does not create or confer any rights for or on any person and does not
operate to bind FDA or the public. An alternative approach may be used if such approach
satisfies the requirements of the applicable statutes, regulations, or both. |
- INTRODUCTION
This guidance is intended to clarify when sponsors should submit final, quality-assured toxicology reports and/or update the Agency on any changes in findings since submission of non-quality-assured reports or reports based on non-quality-assured data.
In November 1995, FDA published a guidance for industry entitled Content and Format of Investigational New Drug Applications (INDs) for Phase 1 Studies of Drugs, Including Well-Characterized, Therapeutic, Biotechnology-Derived Products. The guidance states that
If final, fully quality-assured individual study reports
are not available at the time of IND submission, an integrated summary report of
toxicologic findings based on the unaudited draft toxicologic reports of completed animal
studies may be submitted.... [...] full toxicology department individual study reports
should be available to FDA, upon request, and individual study reports should be available
to FDA, upon request, as final, fully quality-assured documents within 120 days of the start of the human study... [emphasis added].
If the integrated summary is based upon unaudited draft
reports, sponsors should submit an update to their integrated summary 120 days after the
start of the human study(ies)....2
There has been some confusion over when the 120-day clock starts, specifically, whether it means 120 days after the start of the clinical trial, or 120 days after the submission of the toxicology information.
Q: How does FDA measure the start of the 120-day period within which sponsors should submit
updates to their integrated summaries?
A: The Agency measures the 120-day period based on the Agency's receipt (date of receipt stamped on the
IND submission) of the integrated summary report including the toxicology information. If the sponsor does
not submit the final, quality-assured report and update at this time, the sponsor should make the final,
quality-assured report available upon the request of the Agency and update the Agency on any changes
in the findings. In any case, the final, quality-assured report should be submitted with the NDA.
1 This
guidance has been prepared by the Pharmacology and Toxicology staff, Office of Review
Management ORM), Center for Drug Evaluation and Research (CDER) and the Center for
Biologics Evaluation and Research (CBER) in the Food and Drug Administration.
2 See guidance, section III(G)(2), Toxicology: Integrated Summary
|
