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Related Concept Videos

Drug Regulation01:25

Drug Regulation

2.6K
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...
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FDA Approved Drugs: Changes to Approved Drugs01:26

FDA Approved Drugs: Changes to Approved Drugs

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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,...
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Neural Regulation01:37

Neural Regulation

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Digestion begins with a cephalic phase that prepares the digestive system to receive food. When our brain processes visual or olfactory information about food, it triggers impulses in the cranial nerves innervating the salivary glands and stomach to prepare for food.
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Drug Control Governance: Regulatory Bodies and Their Impact01:03

Drug Control Governance: Regulatory Bodies and Their Impact

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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...
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Drug Administration and Therapy Phases: Overview01:26

Drug Administration and Therapy Phases: Overview

1.1K
Drugs, the chemical agents used in diagnosing, treating, or preventing diseases, undergo a four-phase process of development: pharmaceutic, pharmacokinetics, pharmacodynamics, and therapeutic.
The pharmaceutical phase focuses on leveraging the physicochemical properties of the drug to design and manufacture an effective product. Variants include orally administered tablets or capsules, topical creams or ointments, and parenteral-delivery solutions or emulsions.
The pharmacokinetic phase...
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Related Experiment Video

Updated: Dec 30, 2025

Focused Ultrasound Induced Blood-Brain Barrier Opening for Targeting Brain Structures and Evaluating Chemogenetic Neuromodulation
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FDA Perspectives on the Regulation of Neuromodulation Devices.

Timothy Marjenin1, Pamela Scott1, Anita Bajaj1

  • 1Food and Drug Administration, Center for Devices and Radiological Health, Silver Spring, MD, USA.

Neuromodulation : Journal of the International Neuromodulation Society
|January 23, 2020
PubMed
Summary

Navigating the U.S. Food and Drug Administration (FDA) regulatory process is crucial for medical device innovators. This guide explains how to bring safe and effective neuromodulation devices to patients.

Keywords:
Deep brain stimulationimplantneurostimulationnoninvasiveregulationspinal cord stimulationtranscranial magnetic stimulationvagal nerve stimulation

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Area of Science:

  • Neurology
  • Medical Device Regulation

Background:

  • The U.S. Food and Drug Administration (FDA) oversees medical device safety and efficacy.
  • Neuromodulation devices interact with the nervous system and require specific regulatory pathways.

Purpose of the Study:

  • To provide guidance on navigating the FDA's regulatory landscape for neuromodulation devices.
  • To facilitate patient access to innovative neuromodulation technologies.

Main Methods:

  • Review of FDA regulatory guidelines for neurological and physical medicine devices.
  • Analysis of the pathway for medical technologies interfacing with the nervous system.

Main Results:

  • Understanding the FDA's review process is key for device approval.
  • Successful navigation leads to timely patient access.

Conclusions:

  • This article serves as a guide for innovators in the neuromodulation field.
  • Streamlining the regulatory process ensures patient safety and device availability.