IND Safety Reports: Notification Requirements and Format



IND Safety Reports: Notification Requirements and Format

1. Requirements for written IND Safety Reports.

• The sponsor shall notify the FDA and all participating investigators in a written IND Safety Report of:

o Any human adverse event that is (i) Associated with the use of the drug or study treatment(s) and (ii) both Serious and Unexpected.

▪ Note: A sponsor of a clinical research study of a marketed drug is not required to make a Safety Report for any adverse event that occurs as a result of the use of the drug outside of the respective clinical research study.[1]

o Any finding from tests in laboratory animals that suggests a significant risk for human subjects including reports of mutagenicity, teratogenicity, or carcinogenicity.

• Each written IND Safety Report shall be made as soon as possible and in no event later than 15 calendar days after the sponsor’s receipt of the respective adverse event information or laboratory animal data.

• Written IND Safety Reports addressing a human adverse event should be submitted on a FDA Form 3500A; written reports of animal data shall be submitted in narrative format.

o Each written IND Safety Report shall bear prominent identification of its contents; i.e., “IND Safety Report”.

o Each written IND Safety Report shall be submitted to the applicable new drug review division within the FDA’s Center for Drug Evaluation and Research (CDER) or product review division within the FDA’s Center for Biologics Evaluation and Research that has responsibility for review of the respective IND application.

o In each written IND Safety Report, the sponsor shall identify all previously submitted IND Safety Reports concerning a similar adverse event and shall analyze the significance of the adverse event in light of the previous, similar reports.

2. Requirements for telephone or facsimile transmission of IND Safety Reports (for Fatal and Life threatening).

• In addition to the subsequent submission of a written IND Safety Report, the sponsor shall notify the FDA by telephone or by facsimile transmission of any human adverse event that is (i) Associated with the use of the drug; (ii) Unexpected; and (iii) Fatal or Life-threatening.

o Note: A sponsor of a clinical research study of a marketed drug is not required to make a Safety Report for any adverse event that occurs as a result of the use of the drug outside of the respective clinical research study.[2]

• The telephone or facsimile transmission of applicable IND Safety Reports shall be made as soon as possible but in no event later than 7 calendar days after the sponsor’s initial receipt of the respective human adverse event information.

o Telephone or facsimile transmission of applicable IND Safety Reports shall be to the applicable new drug review division within the FDA’s Center for Drug Evaluation and Research (CDER) or product review division within the FDA’s Center for Biologics Evaluation and Research that has responsibility for review of the respective IND application.

3. Requirements for follow-up to submitted IND Safety Reports.[3]

All safety information received by the sponsor shall be promptly investigated.

• Follow-up information to an IND Safety Report shall be submitted to the applicable review division of the FDA as soon as the relevant information is available.

• If the results of a sponsor’s investigation show that an adverse drug experience that was initially determined to not require a written IND Safety Report does, in fact, meet the requirements for reporting; the sponsor shall submit a written IND Safety Report as soon as possible, but in no event later than 15 calendar days after the determination is made.

• Results of a sponsor’s investigation of other safety information shall be submitted, as appropriate, in an Information Amendment or Annual Report.

4. Alternate IND Safety Report formats and frequency.

The FDA may request a sponsor to submit IND Safety Reports in a format or at a frequency that differ from the standard requirements outlined above. The sponsor may also propose and adopt a different IND Safety Report format or frequency; provided that the change is agreed to in advance by the director of the new drug review division of the FDA’s Center for Drug Evaluation and Research (CDER) or product review division of the FDA’s Center for Biologics Evaluation and Research that has responsibility for review of the respective IND application.

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[1] 21 CFR Sec. 312.32 (c)(4)

[2] 21 CFR Sec. 312.32 (c)(4)

[3] 21 CFR Sec. 312.32 (d)

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