The Nature of the Approval Process

September 18, 2014 9:00am

Speakers

James N. Czaban
Partner and Chair, FDA Practice Group
Wiley Rein LLP

Donald Ware
Partner
Foley Hoag LLP

Rx Drugs

  • Understanding the difference between “new drugs” and other drugs
  • Overview of the research, development, and approval process for new drugs
  • The investigational new drug application (IND) — timing, content, and purpose
  • The new drug application (NDA) — timing, content, purpose, and review process
  • Accelerated approval (fast track)
  • Different uses of the REMS process in new drug approvals

Biological Products

  • What are biological products? What does it mean to say that they are also “drugs”?
  • Which “new drugs” require BLAs instead of NDAs?
  • How do the research, development, and approval process for biological products
  • differ from the process for new drugs?
  • The biologics license application (BLA) — timing, content, purpose, and review process
  • Key similarities and differences between the drug and biological product schemes

OTC Products

  • The concept of “OTC” (OTC-ness)
  • The OTC Review — identifying covered drugs and defining a “monograph”
  • OTC versus Rx
  • Overview of how old and new OTC drugs come to market