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Takeaways from the 2019 FDA Complex Generic Drug Product Development Workshop


Post written by Tishina Okegbe, FHI 360


In late September, the Federal Drug Administration (FDA) hosted its second annual Complex Generic Drug Product Development Workshop. Complex generic drugs are classified as such when they contain a complex formulation, active ingredient, route of delivery or dosage form; are a complex drug-device combination product; and/or require early scientific engagement because there is complexity or uncertainty regarding the FDA approval process.


This class of drugs is therapeutically important and can offer product market competition often leading to price reductions that are passed on to consumers. However, bringing a complex generic drug product to market is both time- and resource-intensive for companies, and scientific, legal, and regulatory challenges are often faced.

As a result, the FDA created the Development Workshop as an opportunity to engage with product developers and researchers along the product development pipeline to foster a more robust portfolio of generic products. In addition to the workshop, the FDA has strategically focused on facilitating complex drug product development by implementing several policy initiatives and hosting town halls to communicate directly with companies. The strategy seems to be working as a record number of generic drug product applications were approved in 2018 and 2019.


Read more about six takeaways from the 2019 Complex Generic Drug Product Development Workshop in a blog penned by Lubrizol Life Science Health.

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