International Pharmaceutical Quality
Inside the Global Regulatory Dialogue

The News In Depth

Attention Heightens on Creating an Independent Regulatory Pathway for Introducing Novel Excipients

IPQ’s five part series is exploring the need for: ● a more qualified-for-purpose excipient toolbox that can help address the formulation, quality, and manufacturing challenges posed by a new generation of medicines, and ● a regulatory process that can better accommodate novel excipients.

INTRODUCTION

PART I: FDA’S Novel Excipient Program Proposal and Stakeholder Comments

PART II: IPEC/IQ Thought Leaders on the Novel Excipient Drivers

PART III: Subcutaneous Biotherapeutics, Pediatrics, and Delayed Release

PART IV: USP Initiatives Supporting Novel Excipient Development

PART V: Assessing and Managing Excipient Risks

IPQ would like to thank our sponsors: