Best of June: Top 5 Insights In Drug Formulation and Delivery

#1 - 3 Lesser Known Keys To Effective Biopharma Supplier Engagement

In this article, Fran DeGrazio lays out ways for biopharma companies developing and commercializing combination products and other drug delivery devices to ensure that their product requirements and related documentation needs are well met by suppliers of materials, devices, components, and services.

#2 - Preparing For Combination Product Regulatory Inspections

In Chapter 9 of The Combination Products Handbook, the book’s editor Susan Neadle and chapter co-author Kim Trautmanm outline and comment on key inspection readiness considerations including CGMPs, quality system requirements, drug and device terminology, supplier controls, and FDA guidance.

#3 - Connected Drug Delivery Devices: Emerging Market Trends

Connected drug delivery devices integrate digital connectivity — often via Bluetooth — with traditional drug administration tools. New market research shares emerging growth and trends.

#4 - Overview – FDA Draft Guidance - Essential Drug Delivery Outputs For Devices Intended To Deliver Drugs And Biologics

All future submissions are expected to align with FDA's draft guidance that clarifies the agency's expectations for establishing, evaluating, and controlling Essential Drug Delivery Output (EDDO) requirements.

#5 - Advanced Process Risk Assessment And Control Strategy Development In Solid Oral Dosage Forms

Using four solid oral dosage drugs representing distinct manufacturing strategies, this article showcases that risk-based thinking and robust control strategies mitigates process variability.