Description
This document provides guidance to applicants on submitting abbreviated reports and synopses in lieu of full reports for certain clinical studies, both in marketing applications for new drug and biological products and in supplements to approved applications. This guidance is intended to meet the requirements of Section 118 of the Food and Drug Administration Modernization Act of 1997 (Modernization Act), which directs FDA to issue guidance on when abbreviated study reports may be submitted in new drug applications (NDAs) and biologics license applications (BLAs) in lieu of full reports.
Scope & Applicability
Product Classes
3Regulated under section 351(i) of the PHS Act; Virus, therapeutic serum, toxin, vaccine, or protein applicable to prevention or treatment; Alternative regulation category for products meeting device definition
development program for drug and biological products
Products intended for rare diseases with limited development programs
Stakeholders
2FDA entity with which applicants should confer regarding report formats
Official who may request abbreviated or full study reports
Regulatory Context
Attributes
3characterizing the safety of individual drugs
Evidence of benefit from everyday medical practice.
Defined as fewer than six clinical trials designed to determine efficacy
Identified Hazards
Hazards
1Assessment of toxicity required in a 351(k) BLA
Related CFR Sections (3)
- 21CFR601.2§ 601.2 Applications for biologics licenses; procedures for filing.
(a) General. To obtain a biologics license under section 351 of the Public Health Service Act for any biological product, the manufacturer shall submit an application to the Director, Center for Biologics Evaluation and Research or the Director, Center for Drug Evaluation and Research (see mailing aRead full regulation →
- 21CFR314.50§ 314.50 Content and format of an NDA.
NDAs and supplements to approved NDAs are required to be submitted in the form and contain the information, as appropriate for the particular submission, required under this section. Three copies of the NDA are required: An archival copy, a review copy, and a field copy. An NDA for a new chemical enRead full regulation →
- 21CFR314.101§ 314.101 Filing an NDA and receiving an ANDA.
(a) Filing an NDA.Read full regulation →
See Also (8)
- Advanced Manufacturing Technologies Designation Program (Status: Final)
- Environmental Assessment of Human Drug and Biologics Applications: Guidance for Industry (Status: Final)
- Content and Format of Chemistry, Manufacturing and Controls Information and Establishment Description Information for a Vaccine or Related Product: Guidance for Industry (Status: Final)
- Providing Regulatory Submissions to the Center for Biologics Evaluation and Research (CBER) in Electronic Format - Biologics Marketing Applications: Guidance for Industry (Status: Final)
- Use of Sterile Connecting Devices in Blood Bank Practices: Guidance for Industry (Status: Final)
- Submitting Marketing Applications According to the ICH/CTD Format: General Considerations (Status: Draft)
- Pharmacogenomic Data Submissions; Examples of Voluntary Submissions or Submissions Required Under 21 CFR 312, 314, or 601 (Status: Final)
- Pharmacogenomic Data Submissions: Guidance for Industry (Status: Final)