Description
It is important to harmonize the way to gather and, if necessary, to take action on important clinical safety information arising during clinical development.
Scope & Applicability
Product Classes
4Information should be provided for other treatments including OTC products.
Includes over-the-counter products used by the patient.
Scope of the analytical procedures
Requires analytical comparability per ICH Q5E
Stakeholders
7Bodies responsible for evaluating trial risks and benefits for pregnant participants.; ECs experienced in this population may advise on compensation.
Entity required to conduct postmarket surveillance; entity responsible for submitting postmarket surveillance plans; Entity holding the approved PMA, HDE, or cleared 510(k); The entity responsible for conducting postmarket surveillance and submitting reports.; Entity that can use the checklist as a reference for submissions.
The identification of the reporter (primary source) could be prohibited by certain national or regional confidentiality requirements.; Primary source of the case report; Primary source providing causality assessment; Source of words or short phrases in narrative; The primary source of the information who initially reports the facts in the ICSR
Bodies responsible for evaluating trial risks and benefits for pregnant participants.; IRBs experienced in this population may advise on compensation.
Guidance for Sponsors, Investigators, and Institutional Review Boards
Entity responsible for submitting applications under section 524B
source of exposure reports
Regulatory Context
Attributes
7Investigational status of a product
Assessment of the illness or injury if a hazard occurs; Factor in hazard evaluation regarding illness or injury
Clinical development stage required for IND phase pilot submissions.
Investigational status of a product
Diseases or conditions where the likelihood of death is high.
INN used to identify suspected medicinal product
Information required for expedited reporting of adverse drug reactions.
Identified Hazards
Hazards
1Significant hazard to patient population in life-threatening diseases
Related CFR Sections (2)
- 21CFR10.90§ 10.90 Food and Drug Administration regulations, recommendations, and agreements.
(a) Regulations. FDA regulations are issued in the Federal Register under § 10.40 or § 10.50 and codified in the Code of Federal Regulations. Regulations may contain provisions that will be enforced as legal requirements, or which are intended only as guidance documents and recommendations, or both.Read full regulation →
- 21CFR314.80§ 314.80 Postmarketing reporting of adverse drug experiences.
(a) Definitions. The following definitions of terms apply to this section:Read full regulation →
See Also (8)
- General Considerations for the Clinical Evaluation of Drugs (Status: Final)
- Preparation of Investigational New Drug Products (Human and Animal): Guidance for Industry (Status: Final)
- Clinical Evaluation of Antiepileptic Drugs (adults and children) (Status: Final)
- Hypnotic Drugs--Clinical Evaluation (Status: Final)
- GUIDELINE FOR SUBMITTING SUPPORTING DOCUMENTATION IN DRUG APPLICATIONS FOR THE MANUFACTURE OF DRUG PRODUCTS (Status: Final)
- E7 Studies in Support of Special Populations: Geriatrics (Status: Final)
- S3B Pharmacokinetics: Guidance for Repeated Dose Tissue Distribution Studies (Status: Final)
- S3A Toxicokinetics: The Assessment of Systemic Exposure in Toxicity Studies (Status: Final)