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The FDA's Evaluation of a New Regulatory Pathway – A Discussion on the Approval of Novel Excipients

Excipient (inactive ingredient) selection and qualification for use in a drug product is critical to the success of any pharmaceutical development program. Excipients are vital for ensuring essential drug product properties, such as increasing bioavailability or enabling controlled release of a drug.

However, the current regulatory landscape, or lack of an independent excipient approval pathway, may be limiting the entrance of new excipients in the market and, subsequently, new drug products. In this blog post, the Health team at Lubrizol Life Science (LLS Health) sits down with the Director of Regulatory Strategy and Policy, Meera Raghuram, to discuss the importance of novel excipients and recent actions taken by the FDA.

Learn more about the importance of novel excipients

 

Upcoming Webinar: Enabling Topical Innovation – The Road to the Right Formulation

Topical semisolids can effectively deliver therapeutics to targeted areas, with added benefits of speed, convenient application and reduced risk of side effects. Due to these advantages, this area of drug delivery is steadily growing and primed for innovation. Join LLS Health's webinar on June 17 to:

  • Review topical drug delivery, including types of semisolids, innovation and market trends

  • Understand the process of developing the right semisolid topical formulation, including initial considerations, how to choose a dosage form, evaluation criteria and how to optimize the final product

  • Uncover how the drug, inactive ingredients, and dosage form impact each other and the formulation

  • Discover how to address the safety, efficacy, quality and compliance of your product

Webinar Registration

 

 

Lubrizol Life Science Health is a global partner enabling formulators to develop patient-centric drug products through our differentiated excipient offerings. Contact us today to learn more and see how we can help bring your innovation to life.

 

Contact Lubrizol Life Science Health

 

 

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