CfPA Course: FDA Drug Approval, Regulation and Compliance

May 16, 2016 {ml-event-to} May 17, 2016

FDA senior counsel Gary Yingling will codirect a Center for Professional Advancement (CfPA) course covering current US Food and Drug Administration (FDA) development issues and compliance with respect to manufacturing and marketing human drugs and biologics.

The two-day course will discuss applications to prescription and over-the-counter drugs as well as biotechnology-derived products.

Topics will include:

  • New drug applications, abbreviated new drug applications, and other preapproval documents
  • The Federal Food, Drug, and Cosmetic Act
  • Current Good Manufacturing Practices from training and documentation to inspection, recalls, and reporting
  • The FDA’s authority to declare and enforce regulations