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Related Concept Videos

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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Drug Products: Biologics, Biosimilars and Interchangeables01:28

Drug Products: Biologics, Biosimilars and Interchangeables

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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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Clinically Relevant Drug Product Specifications: Methods of Establishment01:29

Clinically Relevant Drug Product Specifications: Methods of Establishment

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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...
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Related Experiment Video

Updated: Mar 13, 2026

The WATCHMAN Left Atrial Appendage Closure Device for Atrial Fibrillation
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Medical Devices; Custom Devices; Technical Amendment. Final rule; technical amendment.

    Federal Register
    |October 13, 2016
    PubMed
    Summary

    The Food and Drug Administration (FDA) updates custom device regulations to include new requirements from the Food and Drug Administration Safety and Innovation Act (FDASIA). These changes align the FDA

    Area of Science:

    • Regulatory Science
    • Medical Device Regulation

    Background:

    • The Food and Drug Administration (FDA) regulates medical devices.
    • Existing regulations define custom devices and their exemptions.
    • The Federal Food, Drug, and Cosmetic Act (FD&C Act) governs device approval.

    Purpose of the Study:

    • To amend FDA regulations regarding the definition of custom devices.
    • To incorporate new statutory requirements for custom devices as amended by FDASIA.
    • To align regulatory definitions with current federal law.

    Main Methods:

    • Review and amendment of existing FDA regulations.
    • Incorporation of statutory requirements from the FD&C Act, as amended by FDASIA.
    • Introduction of new concepts and procedures for custom devices.

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    Main Results:

    • Updated definition of custom devices.
    • Inclusion of new enumerated statutory requirements.
    • Modification of the custom device exemption.

    Conclusions:

    • The amended regulations align with the FD&C Act as modified by FDASIA.
    • New provisions introduce updated concepts and procedures for custom devices.
    • Ensures regulatory compliance with federal law for custom medical devices.