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Related Concept Videos

Drug Nomenclature01:17

Drug Nomenclature

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During the development of a new pharmaceutical, the manufacturer initially assigns a code name to the drug. Once approved, the drug receives a United States Adopted Name (USAN)—a generic, nonproprietary designation. Upon being listed in the United States Pharmacopeia, this nonproprietary name becomes the drug's official name. Additionally, the manufacturer assigns a proprietary name or trademark, which serves as the brand name under which the drug is marketed. It is worth noting that...
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Drug Regulation01:25

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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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Bioequivalence: Overview01:16

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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,...
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Prescription, Nonprescription and Orphan Drugs01:02

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Prescription drugs require a prescription from a medical practitioner and can only be obtained from a pharmacy. They have many applications, including treating pain, anxiety, and hypertension.
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Drug Control Governance: Regulatory Bodies and Their Impact01:03

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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 Classes and Categories01:25

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Drugs can be classified according to their chemical composition or their intended therapeutic application. For instance, anti-infective agents that possess the ability to eliminate pathogens or suppress their growth and reproduction can be grouped based on the organisms they target or their chemical structure. Furthermore, drugs can be divided into prescription, nonprescription, or controlled substances. Prescription medications, such as antibiotics, require oversight from a licensed healthcare...
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Validation of Therapeutic Agent Conjugation to Polyvinyl Alcohol-Coated Medical Devices
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Certification Marks for Supporting Generic Drug Quality.

Lars Lindgren1, Aaron S Kesselheim2, S Sean Tu3

  • 1University of Pennsylvania Perelman School of Medicine, Philadelphia, Pennsylvania, United States.

The Journal of Law, Medicine & Ethics : a Journal of the American Society of Law, Medicine & Ethics
|April 28, 2025
PubMed
Summary
This summary is machine-generated.

Independent certification marks could boost trust in generic drugs by verifying quality beyond FDA standards. This system offers a cost-effective way to improve oversight, especially with global supply chains and FDA resource limits.

Keywords:
FDAgeneric drug

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Area of Science:

  • Pharmaceutical policy
  • Regulatory science
  • Intellectual property law

Background:

  • Skepticism regarding generic drug quality persists among patients and prescribers.
  • The U.S. Food and Drug Administration's (FDA) oversight is limited by resource constraints and challenges in inspecting global manufacturing facilities.
  • Existing regulatory frameworks may not fully address consumer trust issues in generic medications.

Purpose of the Study:

  • To explore the potential of independent certification marks to enhance the perception and oversight of generic drug quality.
  • To propose a supplementary system that bolsters trust in generic pharmaceuticals without requiring legislative changes.
  • To identify how certification marks can incentivize manufacturers to exceed baseline quality standards.

Main Methods:

  • Conceptual analysis of certification mark systems (e.g., USDA Organic, Energy Star) and their applicability to pharmaceuticals.
  • Evaluation of the potential benefits of independent quality verification for generic drugs.
  • Assessment of the feasibility of implementing such a system alongside current FDA regulations.

Main Results:

  • Certification marks can serve as a valuable tool for communicating drug quality to consumers.
  • Independent verification can incentivize manufacturers to achieve higher quality standards.
  • A certification system could supplement FDA inspections, particularly in a globalized market.

Conclusions:

  • Independent certification marks offer a promising, cost-effective mechanism to improve generic drug quality perception and oversight.
  • This approach can enhance consumer and prescriber confidence in generic medications.
  • Certification marks represent a feasible strategy to bolster trust in the pharmaceutical supply chain.