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Related Concept Videos

Clinical Trials: Overview01:11

Clinical Trials: Overview

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...
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...
Preclinical Development: Overview01:28

Preclinical Development: Overview

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...
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...
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...
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FDA Approved Drugs: Changes to Approved Drugs

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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Related Experiment Video

Updated: Jul 9, 2026

In Vivo Alkaline Comet Assay and Enzyme-modified Alkaline Comet Assay for Measuring DNA Strand Breaks and Oxidative DNA Damage in Rat Liver
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In Vivo Alkaline Comet Assay and Enzyme-modified Alkaline Comet Assay for Measuring DNA Strand Breaks and Oxidative DNA Damage in Rat Liver

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Scientific and Regulatory Approach to Botanical Drug Development: A U.S. FDA Perspective.

Charles Wu1, Su-Lin Lee2, Cassandra Taylor1

  • 1Botanical Review Team, Science Staff, Immediate Office, Office of Pharmaceutical Quality , Center for Drug Evaluation and Research, Food and Drug Administration , 10903 New Hampshire Avenue , Silver Spring , Maryland 20993 , United States.

Journal of Natural Products
|January 25, 2020
PubMed
Summary

Botanical drug development in the U.S. faces challenges despite numerous investigational new drug (IND) applications. Analysis of INDs reveals diverse raw materials and therapeutic areas, highlighting the need for regulatory guidance.

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Last Updated: Jul 9, 2026

In Vivo Alkaline Comet Assay and Enzyme-modified Alkaline Comet Assay for Measuring DNA Strand Breaks and Oxidative DNA Damage in Rat Liver
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Area of Science:

  • Pharmacology and Drug Development
  • Regulatory Science
  • Natural Products Chemistry

Background:

  • The U.S. Food and Drug Administration (FDA) has received over 800 botanical investigational new drug (IND) and pre-IND meeting requests (PIND) prior to 2018.
  • Botanical drug indications span nearly all FDA review divisions, indicating broad research interest.
  • Only two botanical new drug applications (NDAs) have been approved in the U.S. (Veregen in 2006, Fulyzaq in 2012), despite global interest.

Purpose of the Study:

  • To analyze the characteristics of submitted botanical INDs.
  • To identify challenges in the scientific and regulatory review of botanical drug products.
  • To provide an overview of the FDA's experience with botanical drug applications.

Main Methods:

  • Analysis of botanical investigational new drug (IND) applications submitted to the FDA.
  • Review of botanical raw material diversity, including geographic origin and composition (single vs. multiple herbs).
  • Examination of previous human experience and therapeutic areas associated with botanical INDs.

Main Results:

  • Submitted INDs cover a wide range of botanical raw materials from various geographic regions.
  • Applications include both single-herb and multi-herb formulations.
  • Therapeutic areas are diverse, reflecting the broad applicability of botanical compounds.

Conclusions:

  • The chemical and biological complexity of botanicals presents significant challenges in pharmacology, efficacy demonstration, and quality control.
  • The FDA's 2016 revised Botanical Drug Development Guidance aims to facilitate late-phase trials and overall development.
  • Continued analysis and regulatory experience are crucial for advancing botanical drug development.