Description
This technical specifications document represents the Food and Drug Administration's (FDA'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. You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations. If you want to discuss an alternative approach, contact the FDA staff responsible for implementing this guidance. If you cannot identify the appropriate FDA staff, send an email to cder-edata@fda.hhs.gov or cber.cdisc@fda.hhs.gov.
Scope & Applicability
Product Classes
3Products for which batch/lot information is particularly important
examples of components include drug/device combinations
Products combining drug, device, or biological constituents; Generally recommended for Enhanced Documentation; Requires 14971-based framework incorporating ICH Q9; A drug-device combination where the device constituent part detects ingestion.
Stakeholders
5Authority who declares public health emergencies
Entity submitting development data and knowledge; Entity performing the work process for change
Agency staff who do not review sample submissions
Facility to which studies are outsourced
responsible for justifying omission of studies
Regulatory Context
Attributes
10Technical specification for file limits
Product indication used to determine regulatory flexibility
Date used to determine compliance requirements
Trial summary parameter TPHASE
Trial summary parameter ADAPT
Data about data, including audit trails and system logs.
Non-standardized data format
Strongly preferred version for data definition files
study start date is the date on which the study protocol is approved, also known as the study initiation date
Lower limit of quantitation for an analyte
Identified Hazards
Hazards
1Emergency event impacting data standard requirements
Related CFR Sections (1)
- 21CFR312.23§ 312.23 IND content and format.
(a) A sponsor who intends to conduct a clinical investigation subject to this part shall submit an “Investigational New Drug Application” (IND) including, in the following order:Read full regulation →
See Also (8)
- PHS Guideline on Infectious Disease Issues in Xenotransplantation: PHS Guideline (Status: Final)
- Developing Medical Imaging Drug and Biological Products Part 2: Clinical Indications (Status: Final)
- FDA Review of Vaccine Labeling Requirements for Warnings, Use Instructions, and Precautionary Information: Guidance for Industry (Status: Final)
- Pharmacogenomic Data Submissions: Guidance for Industry (Status: Final)
- Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials: Guidance for Industry (Status: Final)
- Considerations for Plasmid DNA Vaccines for Infectious Disease Indications: Guidance for Industry (Status: Final)
- Labeling for Human Prescription Drug and Biological Products — Determining Established Pharmacologic Class for Use in the Highlights of Prescribing Information (Status: Final)
- Systemic Lupus Erythematosus --Developing Medical Products for Treatment (Status: Final)