Related Experiment Video
Updated: May 2, 2026
![An Automated Radiosynthesis of [68Ga]Ga-FAPI-46 for Routine Clinical Use](/_next/image?url=https%3A%2F%2Fcloudfront.jove.com%2FCDNSource%2Fteasers%2F66708.jpg&w=3840&q=50)
10:33
An Automated Radiosynthesis of [68Ga]Ga-FAPI-46 for Routine Clinical Use
Published on: May 24, 2024
1.9K
A tale of two transparency attempts at FDA
1Edmond J. Safra Center for Ethics, Harvard University, USA.
Food and Drug Law Journal
|February 21, 2014
Summary
The FDA's Transparency Initiative faced legal hurdles and leadership issues, unlike its successful FOIA backlog reduction. These factors highlight challenges in administrative agency transparency and institutional change.
Area of Science:
- Public Administration
- Information Science
- Regulatory Policy
Background:
- The U.S. Food and Drug Administration (FDA) has implemented initiatives to enhance information transparency.
- Key initiatives include the Transparency Initiative and efforts to reduce the Freedom of Information Act (FOIA) backlog.
Purpose of the Study:
- To evaluate the effectiveness of the FDA's Transparency Initiative and FOIA backlog reduction.
- To identify factors contributing to the differential success of these transparency efforts.
Main Methods:
- Comparative analysis of two FDA transparency initiatives.
- Examination of legal constraints and leadership influences on operational changes.
Main Results:
- The reduction in the FDA's FOIA backlog was more successful than the Transparency Initiative.
- Legal constraints and political appointee leadership hindered the Transparency Initiative's effectiveness.
Conclusions:
- The Transparency Initiative's shortcomings stemmed from unaddressed legal constraints and leadership dynamics.
- Understanding these principles can inform strategies for stimulating institutional change in administrative agencies.
More Related Videos
10:26Soft Lithographic Procedure for Producing Plastic Microfluidic Devices with View-ports Transparent to Visible and Infrared Light
Published on: August 17, 2017
13.3K
05:45Developmental Toxicity Assay Based on Real-Time Monitoring of Fibroblast Growth Factor Signal Disruption in Human Induced Pluripotent Stem Cells
Published on: October 10, 2025
666
Related Concept Videos
01:25Drug Regulation
3.0K
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...
3.0K
01:13Bioequivalence studies: Biowaivers
430
In certain scenarios, in vitro dissolution tests can replace in vivo bioequivalence studies. This is particularly true when a drug product, though available in varying strengths, maintains proportional similarity in its active and inactive ingredients. In such cases, the need for in vivo bioequivalence studies for lower strength variants may be waived, provided dissolution tests and in vivo studies on the highest strength yield satisfactory results.Bioequivalence can be indicated through...
430
01:26FDA Approved Drugs: Changes to Approved Drugs
343
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,...
343
01:19Pharmacovigilance
2.0K
Post-marketing surveillance is a critical component of pharmaceutical regulation, often uncovering unanticipated adverse drug reactions (ADRs) once a drug is widely used over an extended period.
This process, termed pharmacovigilance, aims to detect, evaluate, and minimize harmful effects related to medication use. The data collection for pharmacovigilance depends on spontaneous reporting systems, where healthcare professionals or patients voluntarily report suspected ADRs.
In some cases, there...
This process, termed pharmacovigilance, aims to detect, evaluate, and minimize harmful effects related to medication use. The data collection for pharmacovigilance depends on spontaneous reporting systems, where healthcare professionals or patients voluntarily report suspected ADRs.
In some cases, there...
2.0K
01:29Clinically Relevant Drug Product Specifications: Methods of Establishment
300
Product specifications define the acceptable quality of a pharmaceutical product by ensuring identity, purity, potency, and strength. These specifications serve as benchmarks during development, manufacturing, and post-approval quality control. Clinically relevant specifications are particularly important because they directly relate to a drug's safety and efficacy in clinical use.Dissolution studies are critical biopharmaceutic tools that link in vitro behavior to in vivo performance. They...
300
01:16Bioequivalence: Overview
2.2K
Pharmaceutical equivalents, by definition, are drug products with the same active ingredient in the same quantities, encapsulated in identical dosage forms, and intended for the same administration routes. These pharmaceutical equivalents are deemed bioequivalent if the bioavailability of the active entity in the drug preparations is similar. Moreover, pharmaceutical equivalents demonstrating bioequivalence are also regarded as therapeutically equivalent. This means that when used as directed,...
2.2K