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Small Molecules, Biologics, and Vaccines: Three Uniquely Divergent Roads to FDA CMC Approval

2021 年 8 月 31 日

In chemistry, manufacturing, and controls (CMC) regulatory writing, there is a difference in the level of detail required for New Drug Applications (NDAs) and Biologic License Application (BLAs) supporting different types of products. The expectations tend to diminish as time elapses and the regulatory authority becomes more familiar with a specific type of medicinal product. Small molecule oral solid products have been submitted to and approved by regulatory authorities more frequently and represent a different set of expectations than are expected for vaccines and biologics. Vaccines and biologics tend to be rather comparable to each other yet they contain significant differences in requirements for certain modules. This program investigates the differences between the small molecule NDA, and the biologic and vaccine BLA. It will tie together the processes required for small molecules, biologics, and vaccines, including relevant information in a company’s regulatory applications, including pertinent regulatory guidelines and the synthesis, production, and/or manufacturing of the compounds and products.

This webcast will provide a high-level overview of the expectations required for Module 3 submissions for a small molecule oral solid product NDA, a parenteral biologic BLA, and a vaccine BLA. The program will start with the small molecule oral solid, progress to the biologic including a brief discussion of post approval changes, and finish with the vaccine.

  • Assessment pathway for determining if user feedback surveys can be leveraged for your device.
  • Understanding of the requirements of a scientifically valid user feedback survey, and where people commonly go wrong.
  • Guidance on ensuring the surveys will meet notified body expectations around scientific validity and other requirements.
  • Definition of the practical regulatory, ethical and data privacy considerations, to confirm your data will be acceptable to all regulatory authorities.
  • Actionable information helping you to chart your course to having a successful PMCF plan and data for ongoing MDR compliance and CE marking.
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