Description
These sample formats for the chemistry, manufacturing, and controls section have been prepared by the PET Steering Committee in the Center for Drug Evaluation and Research at the Food and Drug Administration. This document represents the Agency’s current thinking on the production of these positron emission tomography (PET) drug products. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statues, regulations, or both.
Scope & Applicability
Product Classes
6positron emission tomography drug products; Content and format for NDAs and ANDAs
Subject of the CMC section sample format
Positron Emission Tomography drugs requiring aseptic manufacturing.
Subject of CMC sections and component controls
injectable PET radiopharmaceuticals requiring sterility; injectable PET radiopharmaceuticals requiring sterility assurance
Subject of stability and batch data requirements
Stakeholders
4Entity 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.
responsible for justifying omission of studies
entity submitting marketing applications
new facilities added by the DMF holder
Regulatory Context
Attributes
6EOS used for drug substance composition
concentration of sodium fluoride F18 at the point of entry into the aquatic environment
Specification for auxiliary materials (e.g., ACS, USP)
Determined by the sponsor for the investigational product.; investigational product(s) are stable over the period of use and only used within the current shelf life
Must be high enough to permit tracking of the residue of concern.
stability duration from EOS calibration
Identified Hazards
Hazards
1Pyrogenic substances monitored in cleaning studies
Related CFR Sections (5)
- 21CFR25.20§ 25.20 Actions requiring preparation of an environmental assessment.
Any proposed action of a type specified in this section normally requires at least the preparation of an EA, unless it is an action in a specific class that qualifies for exclusion under §§ 25.30 , 25.31 , 25.32 , 25.33 , 25.34 , or 25.35 :Read full regulation →
- 21CFR314.71§ 314.71 Procedures for submission of a supplement to an approved application.
(a) Only the applicant may submit a supplement to an application.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 →
- 21CFR314.97§ 314.97 Supplements and other changes to an approved ANDA.
(a) General requirements. The applicant must comply with the requirements of §§ 314.70 and 314.71 regarding the submission of supplemental ANDAs and other changes to an approved ANDA.Read full regulation →
- 21CFR314.70§ 314.70 Supplements and other changes to an approved NDA.
(a) Changes to an approved NDA.Read full regulation →
See Also (8)
- National Environmental Policy Act; Environmental Assessments for Tobacco Products; Categorical Exclusions – Small Entity Compliance Guide: Guidance for Industry (Status: Final)
- Acceptance and Filing Reviews for Premarket Approval Applications (PMAs): Guidance for Industry and Food and Drug Administration Staff (Status: Final)
- Over-the-Counter Monograph Order Requests: Format and Content (Status: Draft)
- ANDA Submissions – Prior Approval Supplements Under GDUFA: Guidance for Industry (Status: Final)
- Revising ANDA Labeling Following Revision of the RLD Labeling Guidance for Industry: Guidance for Industry (Status: Final)
- Annual Reportable Labeling Changes for New Drug Applications and Abbreviated New Drug Applications for Nonprescription Drug Products (Status: Draft)
- Environmental Assessment: Questions and Answers Regarding Drugs With Estrogenic, Androgenic, or Thyroid Activity (Status: Final)
- Labeling OTC Human Drug Products Updating Labeling in RLDs and ANDAs (Status: Final)