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In part 2 of a multi-part series, David Schoneker, president, Black Diamond Regulatory Consulting, explains what drives the need for the development of a new excipient and how involved regulators are in the process.
Ahead of Excipient World 2026, PharmTech spoke with David Schoneker, president, Black Diamond Regulatory Consulting about what goes into the development of a new and/or novel excipient. In part 2 of this series, Schoneker talks about the distinction between market volume and technical necessity: while more new excipient products target small-molecule drugs due to their market prevalence, large-molecule therapeutics may require truly novel excipients to achieve commercial viability. These innovations are often the result of collaborative development between excipient manufacturers and pharmaceutical companies aimed at solving specific formulation challenges, improving productivity, or reducing costs.
In part 1 of a multi-part series, David Schoneker, president, Black Diamond Regulatory Consulting, explains the difference between a new excipient and a novel excipient and what goes into developing a new excipient. Watch part one here.
From a regulatory perspective, Schoneker clarifies that regulatory bodies like the FDA are generally not involved in the development process unless there is a significant public health imperative, such as the development of lipid nanoparticles for COVID-19 vaccines or the transition to environmentally friendly inhaler propellants. According to Schoneker,the FDA does not approve excipients in isolation. Unlike the petition process for food additives, pharmaceutical excipients are only evaluated and authorized as part of a specific drug product application. Therefore, the Inactive Ingredient Database (IID)1,2 should not be interpreted as a list of approved substances. Instead, it serves as a precedent-of-use reference, indicating levels and routes of administration that have been previously accepted in approved drug products.
While utilizing an excipient within these established precedents usually facilitates a smoother review, the FDA maintains the authority to require justification for any excipient's use in a new drug context. Understanding this distinction may help pharma companies navigate the path from formulation development to regulatory submission.
Watch the interview above to learn more about what goes into the development of a new excipient. Dave will be participating in the workshop, “Risk Based Framework for Development of New Excipient Products”, at Excipient World 2026 being held in Nashville from May 4-6, 2026.3
