FDA organizes workshop on complex generics

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The US Food and Drug Administration (FDA) has announced that the agency is organizing a workshop on the regulation of complex generics.


The workshop, which will be held on 25‒26 September 2019 at The Hotel at the University of Maryland, USA, is being organized as part of FDA’s plans to advance development of complex generics.

Dr Norman E Sharpless, Acting Commissioner of FDA, will be speaking at the event, which is a continuation from the 2018 workshop on complex generic drug products. The goal of this current science-focused workshop is to communicate to the generics industry how FDA research outcomes guide and facilitate complex generic drug product development.

The agency aims to link science and research on complex drug products to product-specific guidance development, discuss pre-abbreviated new drug application (pre-ANDA) meetings and review, and examine various areas of complex product science.

Complex drug products often have features that make them harder to develop as generics under traditional approaches. These challenges can mean these ANDAs may undergo more assessment cycles than other ANDAs for non-complex generic drug products before receiving FDA approval, which, in turn, may result in limited competition. This is why the agency has included facilitating the development and approval of complex generic drugs in its Drug Competition Action Plan, which was introduced in 2017 to advance new policies aimed at bringing more competition to the drug market [1].

Topics to be covered at the workshop include:
• Pre-ANDA programme update
• FDA’s inactive ingredient database: improvements on the path to 2020
• Scientific and regulatory advances for generic topical and transdermal drug product development
• Characterization of complex injectable active pharmaceutical ingredient (API) and formulations
• Bioequivalence approaches for complex injectable API and formulations
• Complex drug-device combination products – injectable drug products
• Complex drug-device combination products – orally-inhaled and nasal drug products
• Quantitative methods and modelling-informed regulatory decision-making

The workshop is intended for scientists, researchers and regulatory affairs professionals who work on or are interested in working on the development of complex generic drugs. Participants can attend in person or online after registering at https://sbiaevents.com/CGP2019. 

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1. GaBI Online - Generics and Biosimilars Initiative. FDA trying to reduce hurdles for complex generics [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Sep 13]. Available from: www.gabionline.net/Generics/General/FDA-trying-to-reduce-hurdles-for-complex-generics

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Source: US FDA

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