Description
This guidance summarizes the investigational new drug application (IND) process for unapproved positron emission tomography (PET) drugs, makes recommendations on how to submit an IND, provides advice on investigational PET drug access options, and describes the process for requesting permission to charge for an investigational PET drug. This guidance does not describe all the considerations relevant to an Expanded Access submission or to an IND Request to Charge submission. For details about these processes, we encourage sponsors to review the applicable regulations and advice available on the FDA Web site, and consult the review division, if necessary.
Scope & Applicability
Product Classes
5Covered under 21 CFR part 212
Positron Emission Tomography drugs under investigation
PET drugs are defined as diagnostic radiopharmaceuticals.
Submissions that may qualify for a waiver from eCTD requirements
investigational Positron Emission Tomography drugs; Positron Emission Tomography drugs discussed throughout the guidance
Stakeholders
4Entity responsible for submitting applications under section 524B
submission of a statement by an independent certified public accountant; Qualified individual required to review and approve cost recovery calculations.; Professional required to review and approve cost recovery calculations.
Individual authorized to compound drugs under section 503A; Individual authorized to compound under Section 503A
individual who both initiates and conducts a clinical investigation
Regulatory Context
Attributes
3No-observed adverse effect level for histological changes
monitoring and reporting costs for intermediate-size populations
Costs specifically and exclusively attributable to providing the drug to subjects.
Related CFR Sections (14)
- 21CFR312.315§ 312.315 Intermediate-size patient populations.
Under this section, FDA may permit an investigational drug to be used for the treatment of a patient population smaller than that typical of a treatment IND or treatment protocol. FDA may ask a sponsor to consolidate expanded access under this section when the agency has received a significant numbeRead full regulation →
- 21CFR312.8§ 312.8 Charging for investigational drugs under an IND.
(a) General criteria for charging.Read full regulation →
- 21CFR312.33§ 312.33 Annual reports.
A sponsor shall within 60 days of the anniversary date that the IND went into effect, submit a brief report of the progress of the investigation that includes:Read full regulation →
- 21CFR312.32§ 312.32 IND safety reporting.
(a) Definitions. The following definitions of terms apply to this section:Read full regulation →
- 21CFR25.31§ 25.31 Human drugs and biologics.
The classes of actions listed in this section are categorically excluded and, therefore, ordinarily do not require the preparation of an EA or an EIS:Read full regulation →
- 21CFR312.6§ 312.6 Labeling of an investigational new drug.
(a) The immediate package of an investigational new drug intended for human use shall bear a label with the statement “Caution: New Drug—Limited by Federal (or United States) law to investigational use.”Read full regulation →
- 21CFR312.305§ 312.305 Requirements for all expanded access uses.
The criteria, submission requirements, safeguards, and beginning treatment information set out in this section apply to all expanded access uses described in this subpart. Additional criteria, submission requirements, and safeguards that apply to specific types of expanded access are described in §§Read full regulation →
- 21CFR312.320§ 312.320 Treatment IND or treatment protocol.
Under this section, FDA may permit an investigational drug to be used for widespread treatment use.Read full regulation →
- 21CFR312.1§ 312.1 Scope.
(a) This part contains procedures and requirements governing the use of investigational new drugs, including procedures and requirements for the submission to, and review by, the Food and Drug Administration of investigational new drug applications (IND's). An investigational new drug for which an IRead full regulation →
- 21CFR312.40§ 312.40 General requirements for use of an investigational new drug in a clinical investigation.
(a) An investigational new drug may be used in a clinical investigation if the following conditions are met:Read full regulation →
- 21CFR312.42§ 312.42 Clinical holds and requests for modification.
(a) General. A clinical hold is an order issued by FDA to the sponsor to delay a proposed clinical investigation or to suspend an ongoing investigation. The clinical hold order may apply to one or more of the investigations covered by an IND. When a proposed study is placed on clinical hold, subjectRead full regulation →
- 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 →
- 21CFR312.2§ 312.2 Applicability.
(a) Applicability. Except as provided in this section, this part applies to all clinical investigations of products that are subject to section 505 of the Federal Food, Drug, and Cosmetic Act or to the licensing provisions of the Public Health Service Act (58 Stat. 632, as amended ( 42 U.S.C. 201 etRead full regulation →
- 21CFR312.310§ 312.310 Individual patients, including for emergency use.
Under this section, FDA may permit an investigational drug to be used for the treatment of an individual patient by a licensed physician.Read full regulation →
Related Warning Letters (10)
- 2025-12-23
In Vivo Bioavailability-Bioequivalence Studies – Clinical
Maria A. Carballosa, M.D.
- 2025-12-16
CGMP/Positron Emission Tomography (PET) Drugs/Adulterated
3D Imaging Drug Design and Development LLC
- 2025-12-09
Unapproved New Drug/Unlicensed Biological Product/Biologics License Application (BLA)
Celularity, Inc
- 2025-11-18
Sponsor/Investigator
Verdure Sciences, Inc.
- 2025-09-30
Clinical Investigator (Sponsor)
Pamela K. Den Besten, DDS, MS
- 2025-09-23
Clinical Investigator/Sponsor
Ralph A. DeFronzo, M.D.
- 2025-09-09
Clinical Investigator
Shirish M. Gadgeel, M.D.
- 2025-07-15
Clinical Investigator
Mark J. Savant, M.D
- 2025-07-01
Clinical Investigator
Peter Michael, M.D.
- 2025-06-10
Clinical Investigator (Sponsor)
American Behavioral Research Institute, LLC
See Also (8)
- Expanded Access to Investigational Drugs for Treatment Use - Questions and Answers: Guidance for Industry (Status: Final)
- Individual Patient Expanded Access Applications: Form FDA 3926 (Status: Final)
- Chronic Hepatitis C Virus Infection: Developing Direct-Acting Antiviral Drugs for Treatment Guidance for Industry (Status: Final)
- Institutional Review Board (IRB) Review of Individual Patient Expanded Access Submissions for Investigational Drugs and Biological Products: Guidance for IRBs and Clinical Investigators (Status: Final)
- Charging for Investigational Drugs Under an IND: Questions and Answers (Status: Final)
- Expanded Access to Investigational Drugs for Treatment Use: Questions and Answers (Status: Final)
- Informed Consent: Guidance for IRBs, Clinical Investigators, and Sponsors (Status: Final)
- Considerations for the Conduct of Clinical Trials of Medical Products During Major Disruptions Due to Disasters and Public Health Emergencies (Status: Final)