FDA planning more guidance for developers of complex generics

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As part of its efforts to advance the development of generics of complex drugs with the aim of improving patient access to medicines, the US Food and Drug Administration (FDA) announced that it is planning to release new and revised guidance documents for complex generics.


FDA defines complex products as a product with complex active ingredients, formulations, routes of delivery or dosage forms; complex drug-device combination products; and other products where complexity or uncertainty concerning the approval pathway or possible alternative approach would benefit from early scientific engagement.

The agency has already released a series of guidance documents that it says, ‘will advance the development of generic transdermal and topical delivery systems (TDS)’ [1]. The agency has now released a list of guidance that it plans to issue during 2019.

Upcoming product-specific guidances for complex generic drug product development
Date: 1 October 2019

The list, which was updated on 16 September 2019, includes planned product-specific guidance documents for complex generics that FDA plans to issue and the list of product-specific guidance that FDA plans to revise.

All the guidance documents are aimed at ensuring that FDA provides as much scientific and regulatory clarity as possible with respect to complex generics.

FDA has also held a workshop on complex generics as part of its aims to advance the development of complex generics. One of the subjects discussed at the workshop was how to link science and research on complex drug products to product-specific guidance development [2].

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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 2019 Oct 18]. Available from: www.gabionline.net/Guidelines/FDA-issues-guidance-for-developers-of-complex-generics
2. GaBI Online - Generics and Biosimilars Initiative. FDA organizes workshop on complex generics [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Oct 18]. Available from: www.gabionline.net/Guidelines/FDA-organizes-workshop-on-complex-generics

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Source: US FDA

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