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.
Scope & Applicability
Product Classes
7Subject of the guidance document
Broad category including Group 1 and Group 2 agents
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
Radioactive drug or biological products used in nuclear medicine; Products requiring radiation safety assessment
Nonradiolabeled drugs used for radiographic examination
Stakeholders
1Entity responsible for submitting applications under section 524B
Regulatory Context
Attributes
7Characteristic relevant to safety; Characteristic relevant to safety evaluation; The mass or weight of the ligand or carrier, including the radionuclide
Calculations required based on biologic distribution data.
equates partial body doses to a whole body dose
Representation of kinetic behavior for accumulation and clearance
Assessment required for therapeutic protein products.
Characteristic relevant to safety
Combined result of biological elimination and radioactive decay
Identified Hazards
Hazards
1Potential safety signal from adverse events in specific drug classes
Related CFR Sections (8)
- 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 →
- 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 →
- 21CFR600.3§ 600.3 Definitions.
As used in this subchapter:Read 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 →
- 21CFR315.6§ 315.6 Evaluation of safety.
(a) Factors considered in the safety assessment of a diagnostic radiopharmaceutical include, among others, the following:Read full regulation →
- 21CFR312.10§ 312.10 Waivers.
(a) A sponsor may request FDA to waive applicable requirement under this part. A waiver request may be submitted either in an IND or in an information amendment to an IND. In an emergency, a request may be made by telephone or other rapid communication means. A waiver request is required to contain Read full regulation →
See Also (8)
- Oncology Therapeutic Radiopharmaceuticals: Nonclinical Studies and Labeling Recommendations Guidance for Industry (Status: Final)
- Institutional Review Boards Frequently Asked Questions: Guidance for Institutional Review Boards and Clinical Investigators (Status: Final)
- Microdose Radiopharmaceutical Diagnostic Drugs: Nonclinical Study Recommendations: Guidance for Industry (Status: Final)
- Investigational New Drug Applications (INDs) - Determining Whether Human Research Studies Can Be Conducted Without an IND: Guidance for Clinical Investigators, Sponsors, and IRBs (Status: Final)
- Investigational New Drug Applications for Positron Emission Tomography (PET) Drugs (Status: Final)
- PET Drugs--Current Good Manufacturing Practice (CGMP); Small Entity Compliance Guide (Status: Final)
- Radioactive Drug Research Committee: Human Research Without An Investigational New Drug Application (Status: Final)
- PET Drug Products - Current Good Manufacturing Practice (CGMP) (Status: Final)