Standardized Format for Electronic Submission of NDA and BLA Content for the Planning of Bioresearch Monitoring (BIMO) Inspections for CDER Submissions Guidance for Industry | Guideline Explorer

Description

The Food and Drug Administration (FDA or the Agency) is announcing the availability of the guidance for industry entitled "Standardized Format for Electronic Submission of NDA and BLA Content for the Planning of Bioresearch Monitoring (BIMO) Inspections for CDER Submissions." This guidance describes the electronic submission of certain data and information in standardized formats. This information is used by the Center for Drug Evaluation and Research (CDER) in the planning of, and by FDA’s Office of Inspections and Investigations (OII) in the conduct of, BIMO inspections.

Key Topics

Terms and concepts identified from this document

Scope & Applicability

Stakeholders

4

Sponsor

Entity responsible for submitting applications under section 524B

Contract Research Organization

Entity to which obligations may be transferred

Clinical Investigator

Veterinarian responsible for selecting anesthetic regimens and conducting field studies

Institutional Review Board

Governs top dose in clinical studies

Regulatory Context

Regulatory Activities

5

NDA

New Drug Application

BIMO Inspections

Bioresearch Monitoring inspections conducted by FDA

BLA

Biologics License Application

IND

Investigational New Drug submissions

BIMO

Bioresearch Monitoring information

Document Types

8

Clinical Study Report

CSR supported by ADaM datasets; Contains analysis results and animal listings

Case Report Form

collect on the case report form (CRF) the Investigator's clinical interpretation

Protocol

Defines the standard of veterinary practice and limits for anesthetic regimens

Summary-Level Clinical Site Dataset

Standardized data for inspection planning; named clinsite, contains data from major studies

eCTD

Electronic Common Technical Document format for submissions

Bioresearch Monitoring Technical Conformance Guide

Technical specifications for BIMO submissions

Annotated Case Report Form

Mapping of CRF fields to SDTM domains; Mapping of CRF data to SDTM domains; Maps clinical data collection fields to SDTM variables; Source of verbatim terms collected during a study; Maps legacy data elements to standards; aCRF used in study data submissions

subject-level data line listings

provided to OII investigators to verify key study data

Attributes

1

Risk-based model

Model used to select sites for inspection

Standards & References

External Standards

1

FDA Data Standards Catalog

describes exchange format for clinical study datasets

Related CFR Sections (9)

21CFR312.58§ 312.58 Inspection of sponsor's records and reports.
(a) FDA inspection. A sponsor shall upon request from any properly authorized officer or employee of the Food and Drug Administration, at reasonable times, permit such officer or employee to have access to and copy and verify any records and reports relating to a clinical investigation conducted undRead full regulation →
21CFR312.68§ 312.68 Inspection of investigator's records and reports.
An investigator shall upon request from any properly authorized officer or employee of FDA, at reasonable times, permit such officer or employee to have access to, and copy and verify any records or reports made by the investigator pursuant to § 312.62 . The investigator is not required to divulge sRead full regulation →
21CFR314.106§ 314.106 Foreign data.
(a) General. The acceptance of foreign data in an application generally is governed by § 312.120 of this chapter .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 →
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 →
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 →
21CFR314.126§ 314.126 Adequate and well-controlled studies.
(a) The purpose of conducting clinical investigations of a drug is to distinguish the effect of a drug from other influences, such as spontaneous change in the course of the disease, placebo effect, or biased observation. The characteristics described in paragraph (b) of this section have been develRead full regulation →
21CFR312.62§ 312.62 Investigator recordkeeping and record retention.
(a) Disposition of drug. An investigator is required to maintain adequate records of the disposition of the drug, including dates, quantity, and use by subjects. If the investigation is terminated, suspended, discontinued, or completed, the investigator shall return the unused supplies of the drug tRead full regulation →
21CFR312.64§ 312.64 Investigator reports.
(a) Progress reports. The investigator shall furnish all reports to the sponsor of the drug who is responsible for collecting and evaluating the results obtained. The sponsor is required under § 312.33 to submit annual reports to FDA on the progress of the clinical investigations.Read full regulation →

Enforcement Impact

Deficiencies cited in Warning Letters referencing the same regulations

Failure to ensure that the investigation was conducted according to the investigational plan

21

Failure to submit an Investigational New Drug application (IND)

9

Failure to obtain informed consent

5

Unapproved new drug

5

Misbranded drug

4

Failed to ensure that the investigation was conducted according to the investigational plan

3

Enrollment of subjects who do not meet eligibility criteria

3

Failure to submit INDs for the conduct of clinical investigations

3

Unlicensed biological product

2

unapproved new drugs

2

Recent Cases

Related Warning Letters (10)

Related MFDS Guidelines

Korean regulatory guidelines covering similar topics