FDA new and revised guidances for complex generics

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The US Food and Drug Administration (FDA) has announced new and revised product-specific guidances to support the development and approval of safe and effective complex generic drug products.

Nanoparticle V13J18

FDA typically issues current new and revised product-specific guidances on a quarterly basis or as required. The current guidances on complex generic drugs were issued on 18 November 2020. When finalized, such guidances will describe FDA’s current position on how best to develop generic drug versions of specific reference drugs. They aim to help the generic pharmaceutical industry identify the most appropriate methodology and evidence needed to support a specific generic drug’s approval.

FDA describes a complex generic drug is a product with a complex:

  • active ingredient(s), e.g. peptides, polymeric compounds, complex mixtures of APIs, naturally sourced ingredients
  • formulation, e.g. colloids
  • route of delivery, e.g. dermatological products, complex ophthalmological products, and those with formulations such as suspensions, emulsions or gels
  • dosage form, e.g. metered dose inhalers, extended release injectables
  • drug-device combination products, e.g. auto injectors, metered dose inhalers

Complex generics also include other products where complexity and/or uncertainty concerning the approval pathway or possible alternative approaches would benefit from early scientific engagement.

FDA’s list of product-specific guidances include information on the active ingredient(s), the route of administration and dosage form, and the reference listed drug application number. In addition, the list of guidances for complex generic drug products under revision also includes the planned revision categories.

For revised guidances, the planned revision categories briefly describe the nature of the anticipated revisions, as either major, minor or editorial.

The recent new and revised guidances for complex generic products build on those issued in previous years [1-3].

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References
1. GaBI Online - Generics and Biosimilars Initiative. FDA issues guidance for developers of complex generics [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Nov 27]. Available from: www.gabionline.net/Guidelines/FDA-issues-guidance-for-developers-of-complex-generics 
2. GaBI Online - Generics and Biosimilars Initiative. FDA releases product specific guidance to increase generics competition [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Nov 27]. Available from: www.gabionline.net/Guidelines/FDA-releases-product-specific-guidance-to-increase-generics-competition 
3. GaBI Online - Generics and Biosimilars Initiative. FDA planning more guidance for developers of complex generics. [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Nov 27]. Available from: www.gabionline.net/Guidelines/FDA-planning-more-guidance-for-developers-of-complex-generics 

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