While many drugs can take up to 12 years from invention to market, the approval of certain medications in the treatment of serious conditions may be expedited through a variety of processes. This CE offering explains the labyrinthine mechanisms that can prevent or accelerate the approval of new drugs by the Food and Drug Administration and how these actions can affect a patient’s quality of life.
By investing in this presentation, you will gain a greater understanding of the financial considerations involved in drug approval and patient rights to try an investigational new drug. This session also discusses which drugs may or may not be covered by insurance companies, which will help you advocate for the safest, most efficacious drug therapies for your patients.
Topics covered in this session include the following:
- Breakthrough Therapy Designation
- Fast Track and Accelerated Approval
- Priority Review
- Orphan Drug Designation