Jove
Visualize
Contact Us
JoVE
x logofacebook logolinkedin logoyoutube logo
ABOUT JoVE
OverviewLeadershipBlogJoVE Help Center
AUTHORS
Publishing ProcessEditorial BoardScope & PoliciesPeer ReviewFAQSubmit
LIBRARIANS
TestimonialsSubscriptionsAccessResourcesLibrary Advisory BoardFAQ
RESEARCH
JoVE JournalMethods CollectionsJoVE Encyclopedia of ExperimentsArchive
EDUCATION
JoVE CoreJoVE BusinessJoVE Science EducationJoVE Lab ManualFaculty Resource CenterFaculty Site
Terms & Conditions of Use
Privacy Policy
Policies

Related Concept Videos

Drug Regulation01:25

Drug Regulation

3.2K
Drug regulation encompasses the management of drug usage by evaluating its safety and efficacy through assessments conducted by regulatory authorities. Regrettably, the history of drug regulation is marred by several catastrophic events. One such incident is the Elixir Sulfanilamide tragedy, in which the toxic compound diethyl glycol was included in a sweet-tasting medication, leading to numerous fatalities. This event prompted the enactment of the Food, Drug, and Cosmetic Act in 1938. Under...
3.2K
FDA Approved Drugs: Changes to Approved Drugs01:26

FDA Approved Drugs: Changes to Approved Drugs

286
Post-approval, manufacturers may modify an approved new or generic drug product. Such modifications can encompass alterations in the Active Pharmaceutical Ingredient (API), manufacturing process, formulation, batch size, manufacturing site, and container closure system (FDA Guidance for Industry, April 2004). Often, a drug product may undergo multiple changes.These modifications require careful evaluation to determine their potential impact on the drug product's identity, strength, quality,...
286
Clinical Trials: Overview01:11

Clinical Trials: Overview

5.1K
Clinical development focuses on how the drug will interact with the human body and encompasses four key phases of clinical trials, each serving a specific purpose in assessing the safety and effectiveness of new drugs. These phases overlap and build upon one another. Phase I involves a small group of healthy volunteers (typically 20-80 individuals) or, in cases where significant toxicity is expected, patients with the targeted disease, such as cancer or AIDS. The volunteers are tested for...
5.1K
Radiological Investigation III: Pulmonary Angiogram and PET Scan01:13

Radiological Investigation III: Pulmonary Angiogram and PET Scan

504
Radiological investigations are paramount in the diagnosis and management of various pulmonary diseases. Two essential investigations are the Pulmonary Angiogram and the Positron Emission Tomography (PET) Scan.
Pulmonary Angiogram
A Pulmonary Angiogram is an invasive procedure involving injecting a contrast medium through a catheter threaded into the pulmonary artery or the right side of the heart to visualize the pulmonary vasculature. Computed Tomography (CT) scans have mainly replaced this...
504
Drug Products: Biologics, Biosimilars and Interchangeables01:28

Drug Products: Biologics, Biosimilars and Interchangeables

293
Body:Biologics, derived from living sources such as humans, animals, or microorganisms, represent a significant category of pharmaceuticals. These complex molecules, developed through advanced biotechnological methods or purified from natural sources, include essential medical treatments like insulin and growth hormones. The complexity of biologics arises from their large molecular structures and the intricate processes required for their production, making them distinct from conventional...
293
Preclinical Development: Overview01:28

Preclinical Development: Overview

6.1K
Preclinical development consists of a series of tests that ensure the safety and efficacy of a new therapeutic compound before it is tested in humans. There are four main phases to this process. First, safety pharmacology tests are conducted to ensure the drug does not produce any acutely harmful effects. These tests examine parameters such as bronchoconstriction, cardiac dysrhythmias, blood pressure changes, and ataxia. Next, preliminary toxicological testing is performed to determine the...
6.1K

You might also read

Related Articles

Articles linked to this work by shared authors, journal, and citation graph.

Sort by
Same author

Regarding LNT: Scientifically Worthless and Increasingly Indefensible; Regarding LNT: NRC Wrongfully Rejects Petitions to End LNT Model Use.

Journal of nuclear medicine : official publication, Society of Nuclear Medicine·2022
Same author

Nuclear Medicine Procedures Do Not Pose Cancer Risks in Women-Unappreciated or Otherwise.

Journal of nuclear medicine : official publication, Society of Nuclear Medicine·2018
Same author

Well-Founded Recommendations for Radioactive Iodine Treatment of Differentiated Thyroid Cancer Require Balanced Study of Benefits and Harms.

Journal of clinical oncology : official journal of the American Society of Clinical Oncology·2018
Same author

Eliminating Use of the Linear No-Threshold Assumption in Medical Imaging.

Journal of nuclear medicine : official publication, Society of Nuclear Medicine·2017
Same author

Commentary: NRC Requests Comments on Draft Guidance.

Journal of nuclear medicine : official publication, Society of Nuclear Medicine·2017
Same author

Destroying the Linear No-threshold Basis for Radiation Regulation: A Commentary.

Dose-response : a publication of International Hormesis Society·2016

Related Experiment Video

Updated: Feb 21, 2026

Automated Radiochemical Synthesis of [18F]3F4AP: A Novel PET Tracer for Imaging Demyelinating Diseases
11:03

Automated Radiochemical Synthesis of [18F]3F4AP: A Novel PET Tracer for Imaging Demyelinating Diseases

Published on: May 29, 2017

10.5K

How Should the FDA Review Diagnostic Radiopharmaceuticals?

Carol S Marcus1

  • 1Departments of Molecular and Medical Pharmacology, Radiation Oncology, and Radiological Sciences, David Geffen School of Medicine, University of California, Los Angeles, California csmarcus@ucla.edu.

Journal of Nuclear Medicine : Official Publication, Society of Nuclear Medicine
|October 14, 2017
PubMed
Summary

This article proposes a new FDA review process for diagnostic radiopharmaceuticals, suggesting expert committees determine data requirements. This aims to streamline approvals and ensure radiopharmaceutical-specific regulations.

Keywords:
FDA regulationdiagnostic radiopharmaceutical advisory committeediagnostic radiopharmaceutical regulation

More Related Videos

An Automated Radiosynthesis of [68Ga]Ga-FAPI-46 for Routine Clinical Use
10:33

An Automated Radiosynthesis of [68Ga]Ga-FAPI-46 for Routine Clinical Use

Published on: May 24, 2024

1.6K
Radiosynthesis, Quality Control, and Small Animal Positron Emission Tomography Imaging of 68Ga-Labelled Nano Molecules
09:55

Radiosynthesis, Quality Control, and Small Animal Positron Emission Tomography Imaging of 68Ga-Labelled Nano Molecules

Published on: October 4, 2024

981

Related Experiment Videos

Last Updated: Feb 21, 2026

Automated Radiochemical Synthesis of [18F]3F4AP: A Novel PET Tracer for Imaging Demyelinating Diseases
11:03

Automated Radiochemical Synthesis of [18F]3F4AP: A Novel PET Tracer for Imaging Demyelinating Diseases

Published on: May 29, 2017

10.5K
An Automated Radiosynthesis of [68Ga]Ga-FAPI-46 for Routine Clinical Use
10:33

An Automated Radiosynthesis of [68Ga]Ga-FAPI-46 for Routine Clinical Use

Published on: May 24, 2024

1.6K
Radiosynthesis, Quality Control, and Small Animal Positron Emission Tomography Imaging of 68Ga-Labelled Nano Molecules
09:55

Radiosynthesis, Quality Control, and Small Animal Positron Emission Tomography Imaging of 68Ga-Labelled Nano Molecules

Published on: October 4, 2024

981

Area of Science:

  • Nuclear medicine
  • Radiopharmaceutical science
  • Regulatory affairs

Background:

  • Current U.S. Food and Drug Administration (FDA) review processes for diagnostic radiopharmaceuticals may not be optimal.
  • A historical overview of radiopharmaceutical regulation is presented.

Purpose of the Study:

  • To reconsider and propose improvements to the FDA's review process for diagnostic radiopharmaceuticals.
  • To ensure regulatory requirements are specific to radiopharmaceuticals.

Main Methods:

  • Analysis of mass characteristics of common nonradioactive drugs and diagnostic radiopharmaceuticals.
  • Historical review of radiopharmaceutical regulation.
  • Proposal for an external advisory committee structure.

Main Results:

  • Current review processes may include data of questionable usefulness.
  • A structured advisory committee could improve efficiency and specificity.

Conclusions:

  • The FDA should collaborate with professional societies like the Society of Nuclear Medicine and Molecular Imaging and the American College of Nuclear Medicine.
  • An expert-led advisory committee should determine and review data requirements for radiopharmaceutical manufacturers and compounders.
  • This approach would lead to radiopharmaceutical-specific requirements, potentially reducing unnecessary data collection.