Combination Products: Development and CMC Requirements for Registration of Drug Delivery Devices and Prefilled Systems

  • Commonly used drug delivery devices – technologies, design, materials, and performance characteristics.
  • Selecting materials and manufacturing components for drug delivery devices.
  • How to interpret and comply with current FDA regulatory requirements for combination products; what combination product regulations, guidance and standards do and do not exist, or apply; how to manage gaps in the regulatory framework.
  • How to comply FDA’s Final Rule and guidance: Current Good Manufacturing Practice Requirements for Combination Products; requirements for pharmaceutical and medical device companies, contract manufacturers and contract manufacturers and constituent part and component part manufacturers.
  • How to report post-approval design and manufacturing changes.
  • How to conduct “bridging studies” to support presentation switches (e.g., prefilled syringe to autoinjector).
  • Compendial and harmonized standards for drug delivery devices and their materials and components.
  • How to interpret and conform to FDA draft and final guidance documents, including Technical Considerations for Pen, Jet, and Related Injectors Used with Drugs and Biological products, and Container Closure Systems for Packaging Human Drugs and Biologics.
  • How to assess the biocompatibility of materials used to manufacture of drug delivery devices components; how to evaluate chemical and toxicological reports from suppliers.
  • Current guidance and standards related to extractables and leachables; industry “best practices”; efficient and compliant extractable and leachable study work flows