Related Experiment Video

Updated: Aug 29, 2026

Validation of Therapeutic Agent Conjugation to Polyvinyl Alcohol-Coated Medical Devices
06:34

Validation of Therapeutic Agent Conjugation to Polyvinyl Alcohol-Coated Medical Devices

Published on: November 29, 2024

Risk assessment of drugs, biologics and therapeutic devices: present and future issues

    Pharmacoepidemiology and Drug Safety
    |February 7, 2004
    PubMed
    Abstract

    Insights

    The US system for detecting adverse effects of therapeutics is suboptimal. Improving therapeutic risk assessment requires enhanced research, data systems, education, funding, and stakeholder engagement for better public health outcomes.

    Area of Science:

    • Pharmacovigilance and Drug Safety
    • Regulatory Science
    • Public Health Policy

    Background:

    • The current United States system for detecting adverse effects of therapeutics, including drugs, devices, and biological products, is identified as suboptimal.
    • This report is part of a series of workshops coordinated by the Centers for Education and Research on Therapeutics (CERTs) focused on managing therapeutic risks versus benefits.

    Purpose of the Study:

    • To present the findings of an expert workshop dedicated to assessing therapeutic risks.
    • To identify deficiencies in the current US system for post-approval therapeutic risk assessment.

    Main Methods:

    • Convened a workshop with leaders from academia, industry, government, and constituency groups.
    • Focused on post-approval procedures within the US, while incorporating relevant international perspectives and participants.

    Main Results:

    • Delineated substantial deficiencies within the existing US system for therapeutic risk assessment.
    • Identified key areas for improvement: research in risk assessment methodologies, enhancement of data-handling systems, healthcare worker education, resource allocation, and constituency building.

    Conclusions:

    • Global coordination of risk assessment requires leadership across multiple levels.
    • Addressing identified gaps will yield benefits for industry, health authorities, government agencies, healthcare providers, and the public.

    More Related Videos

    A Validatable Droplet Digital Polymerase Chain Reaction Assay for the Detection of Adeno-Associated Viral Vectors in Bioshedding Studies of Tears07:43

    A Validatable Droplet Digital Polymerase Chain Reaction Assay for the Detection of Adeno-Associated Viral Vectors in Bioshedding Studies of Tears

    Published on: July 14, 2023

    Related Concept Videos

    Drug Products: Biologics, Biosimilars and Interchangeables01:28

    Drug Products: Biologics, Biosimilars and Interchangeables

    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...
    Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches01:23

    Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches

    Biopharmaceutical studies constitute a vital field aiming to enhance drug delivery methods and refine therapeutic approaches, drawing upon diverse interdisciplinary knowledge. In research methodologies, the choice between controlled and non-controlled studies significantly influences the study's reliability and accuracy.
    Non-controlled studies, commonly employed for initial exploration, lack a control group, rendering them susceptible to biases and external influences. In contrast, controlled...
    Biopharmaceutical Factors Influencing Drug Product Design: Overview01:22

    Biopharmaceutical Factors Influencing Drug Product Design: Overview

    Rational drug product design integrates knowledge of the drug’s physicochemical properties, formulation components, manufacturing techniques, and intended route of administration. Each factor influences the drug’s performance, including how it is released, absorbed, and eliminated in the body.The physicochemical properties of a drug—such as solubility, stability, and particle size—affect its compatibility with excipients and the choice of dosage form. Excipients, though pharmacologically...
    Pharmacovigilance01:19

    Pharmacovigilance

    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...
    Drug Regulation01:25

    Drug Regulation

    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...
    Drug Control Governance: Regulatory Bodies and Their Impact01:03

    Drug Control Governance: Regulatory Bodies and Their Impact

    Drug control governance involves the oversight and regulation of pharmaceuticals to ensure their safety and efficacy while preventing illegal drug use and trafficking. Regulatory bodies, including the US Food and Drug Administration (FDA) and the European Union's European Medicines Agency (EMA), play a central role in this process. These agencies evaluate the safety and efficacy of drugs before they can be marketed. They fund clinical trials and assess the benefits and risks associated with a...