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
www.fda.gov/drugs/guidances-drugs/upcoming-product-specific-guidances-complex-generic-drug-product-development

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].

Related article
FDA releases new patient guidance on biosimilars

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 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

Permission granted to reproduce for personal and non-commercial use only. All other reproduction, copy or reprinting of all or part of any ‘Content’ found on this website is strictly prohibited without the prior consent of the publisher. Contact the publisher to obtain permission before redistributing.

Copyright – Unless otherwise stated all contents of this website are © 2019 Pro Pharma Communications International. All Rights Reserved.