Combination Products: Understanding FDA Requirements for the Development, Registration and Marketing of Prefilled Syringes, Drug Delivery Devices and Systems

  • Drug and biologic delivery technologies
  • What combination product regulations, guidance and standards do and do not exist, how to interpret, comply or conform to them and how to manage gaps in the regulatory framework
  • How to comply with the final rule on combination product good manufacturing practices and its impact on pharmaceutical companies, contract manufacturers and device constituent part and component part manufacturers
  • How to interpret and conform to recommendations in FDA-OCP guidance on technical considerations for pen, jet, and related injectors used with drugs and biological products
  • How to structure and format combination product CTD applications and labeling
  • How to interpret and apply the recommendations of FDA human factors related guidance documents
  • How and why to implement design controls and human factors usability/design validation studies and current trends in utilizing these tools in pharmaceutical development
  • How to report post-approval design and manufacturing changes to marketing applications and how and when to switch combination product presentations (e.g., vial to prefilled syringe, prefilled syringe to autoinjector); how to “bridge” presentations
  • Registration and Listing requirements for combination products