Description
FDA is announcing the availability of a final guidance for industry entitled “Providing Regulatory Submissions in Electronic Format: IND Safety Reports.” This guidance finalizes the draft guidance of the same name published on October 30, 2019 (84 FR 58158), and describes the electronic format sponsors will be required to use when they electronically submit IND safety reports to CDER and CBER for serious and unexpected suspected adverse reactions, as required under 21 CFR 312.32(c)(1)(i). FDA is establishing the electronic format requirements described in this final guidance under section 745A(a) of the FD&C Act (21 U.S.C. 379k-1(a)).
Scope & Applicability
Product Classes
1Includes investigator-sponsored and expanded access INDs, exempted from 745A(a)
Stakeholders
2Any person or group of persons marketing, manufacturing, processing, or developing a drug; Entity maintaining information for demonstrations of safety and effectiveness
responsible for justifying omission of studies
Identified Hazards
Hazards
1Unplanned event that may justify a temporary waiver.
Related CFR Sections (4)
- 21CFR312.10§ 312.10 Waivers.
(a) A sponsor may request FDA to waive applicable requirement under this part. A waiver request may be submitted either in an IND or in an information amendment to an IND. In an emergency, a request may be made by telephone or other rapid communication means. A waiver request is required to contain Read full regulation →
- 21CFR320.31§ 320.31 Applicability of requirements regarding an “Investigational New Drug Application.”
(a) Any person planning to conduct an in vivo bioavailability or bioequivalence study in humans shall submit an “Investigational New Drug Application” (IND) if:Read full regulation →
- 21CFR10.115§ 10.115 Good guidance practices.
(a) What are good guidance practices? Good guidance practices (GGP's) are FDA's policies and procedures for developing, issuing, and using guidance documents.Read full regulation →
- 21CFR312.32§ 312.32 IND safety reporting.
(a) Definitions. The following definitions of terms apply to this section:Read full regulation →
See Also (8)
- Developing Medical Imaging Drug and Biological Products Part 1: Conducting Safety Assessments (Status: Final)
- Investigational New Drug Applications Prepared and Submitted by Sponsor-Investigators (Status: Draft)
- Microdose Radiopharmaceutical Diagnostic Drugs: Nonclinical Study Recommendations: Guidance for Industry (Status: Final)
- Information Sheet Guidance for Sponsors, Clinical Investigators, and IRBs Frequently Asked Questions Statement of Investigator (Form FDA 1572) (Revision 1): Draft Information Sheet Guidance for Sponsors, Clinical Investigators, and IRBs Frequently Asked Questions Statement of Investigator (Form FDA 1572) (Revision 1) (Status: Draft)
- Questions and Answers on Biosimilar Development and the BPCI Act Guidance for Industry: Guidance for Industry (Status: Final)
- Enforcement Policy Regarding Investigational New Drug Requirements for Use of Fecal Microbiota for Transplantation to Treat Clostridium difficile Infection Not Responsive to Standard Therapies: Guidance for Industry (Status: Final)
- Providing Regulatory Submissions in Electronic Format — Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications Guidance for Industry (Status: Final)
- Safety Reporting Requirements for INDs (Investigational New Drug Applications) and BA/BE (Bioavailability/Bioequivalence) Studies: Guidance for Industry and Investigators (Status: Final)