Description
This guidance is one of three guidances intended to assist developers of medical imaging drug and biological products (medical imaging agents) in planning and coordinating their clinical investigations and preparing and submitting investigational new drug applications (INDs), new drug applications (NDAs), biologics license applications (BLAs), abbreviated NDAs (ANDAs), and supplements to NDAs or BLAs. The three guidances are: Part 1: Conducting Safety Assessments; Part 2: Clinical Indications; and Part 3: Design, Analysis, and Interpretation of Clinical Studies.
Key Topics
Terms and concepts identified from this document
Scope & Applicability
Product Classes
9Subject of the guidance document
Products subject to section 506C notification requirements
The drug being tested in clinical trials for MDS.
single biological product licensed under section 351(a) of the PHS Act; U.S.-licensed reference product used for comparative analytical assessment; analytical studies that demonstrate that the proposed product is highly similar to the reference product
Requires analytical comparability per ICH Q5E
Category of medical imaging agents
Low doses not expected to elicit late radiation toxic effects; Usually gamma emitters given in lower activities than therapeutic radiopharmaceuticals
An article intended for use in the diagnosis or monitoring of a disease exhibiting spontaneous disintegration of unstable nuclei.; A diagnostic radiopharmaceutical may be intended to evaluate patients in an emergency room.
diagnostic or therapeutic patient management indication
Stakeholders
1Entity responsible for submitting applications under section 524B
Regulatory Context
Regulatory Activities
8Using information from phase 3 studies to characterize impact of renal function
regulatory goal supported by early endpoints
Investigational New Drug submissions
New Drug Application
Biologics License Application
Abbreviated New Drug Application
Rule does not apply to products marketed under an NDA
Submission requirement for vaccine labeling
Document Types
1performing label review for each new batch
Attributes
8Property of biological medical imaging agents that may pose significant patient risk.
Closeness of agreement between a series of measurements from multiple samplings.; Performance characteristic measured by intermediate precision; Performance characteristic to be validated
Performance characteristic assessed via linearity experiment
reliability includes accuracy, completeness, and traceability
measure of test validity
measure of test validity
Ability to detect intended mechanism of action without interference; Performance characteristic to be validated
Analysis by sex of clinical performance measures such as sensitivity
Technical Details
Substances
10iodinated compounds used in radiography and CT
Men presenting with abnormal prostate specific antigen testing.
risk of use of a contrast agent should also be considered
developed as an aid in the diagnosis of lung cancer
Active ingredient in gadolinium products is considered the entire complexed molecule
microbubbles, microaerosomes, and related microparticles used in diagnostic ultrasonography
Radionuclide component of a radiopharmaceutical
Example of a radionuclide detected in vivo.
Example of a radionuclide detected in vivo.
Used to detect unique tumor antigens.
Testing Methods
10Imaging modality for diagnostic radiopharmaceuticals
An independent method of measuring the same variable being measured by the investigational drug
measures used to express precision
measures used to express precision
Compare the new test added to the current standard test battery to a truth standard such as pathology.
Prospective study comparing interventions against a control
recommended to document disease activity in all involved segments
Safety assessment for patients undergoing screening during the study
invasive diagnostic testing for cardiac patients
Source of radiological data
Processes
8diagnosis or monitoring with a variety of modalities, such as radiography
processes that took place during the conduct of the trial
evaluate the effect of investigational drugs added to standard chemotherapy
Optical imaging during oncologic surgery aims to optimize tumor resection
diagnosis or monitoring with a variety of modalities, such as computed tomography (CT)
diagnosis or monitoring with a variety of modalities, such as ultrasonography
diagnosis or monitoring with a variety of modalities, such as magnetic resonance imaging (MRI)
diagnosis or monitoring with a variety of modalities, such as radionuclide imaging
Clinical Concepts
10Indications for medical imaging agents including structure delineation; A category of labeled indications for medical imaging agents.
Number of events for Nonfatal Myocardial Infarction in trials
Example of a cancer type treated by tissue agnostic drugs
Disease state not addressed by the general indication in this guidance.
functional evaluation of cardiac anatomy
include estimates of acute morbidity and mortality; Deaths included in the public health impact evaluation.
include estimates of acute morbidity (i.e., acute illnesses); Acute illnesses included in the public health impact evaluation.
Disease or pathology detection or assessment
A category of labeled indications for medical imaging agents.
A category of labeled indications for medical imaging agents.
Identified Hazards
Hazards
1potential harm from imaging results without defined benefits
Standards & References
Specifications
5Independent method of measuring the same variable being measured by the investigational drug.
NPV requirement for supporting de-escalation of treatment
PPV requirement for supporting escalation of treatment
ability to assess unequivocally the analyte in the presence of components which may be expected to be present
Index used for quantifying bias in exposure validation
Related CFR Sections (4)
- 21CFR361.1§ 361.1 Radioactive drugs for certain research uses.
(a) Radioactive drugs (as defined in § 310.3(n) of this chapter ) are generally recognized as safe and effective when administered, under the conditions set forth in paragraph (b) of this section, to human research subjects during the course of a research project intended to obtain basic informationRead full regulation →
- 21CFR310.3§ 310.3 Definitions and interpretations.
As used in this part:Read full regulation →
- 21CFR315.2§ 315.2 Definition.
For purposes of this part, diagnostic radiopharmaceutical means:Read full regulation →
- 21CFR601.31§ 601.31 Definition.
For purposes of this part, diagnostic radiopharmaceutical means:Read full regulation →
See Also (8)
- Microdose Radiopharmaceutical Diagnostic Drugs: Nonclinical Study Recommendations: Guidance for Industry (Status: Final)
- Study Data Technical Conformance Guide - Technical Specifications Document (Status: Final)
- PHS Guideline on Infectious Disease Issues in Xenotransplantation: PHS Guideline (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)