Introduction to Generic Regulations in the US
This course on Generics is intended to be a follow on for students who have taken the Fundamental course. As approximately 85% of all prescriptions in the US are filled with a generic product, knowledge of the regulatory space related to Generics will be key for persons contemplating a career in regulatory affairs. The course on generics builds on the lifecycle of the overall drug development process by focusing on what happens to a new drug as the underlying patent expires or is challenged. It covers the barriers, or the lack thereof, of submitting an Abbreviated New Drug Application (ANDA) and the recent changes made by the FDA’s Office of Generic Drugs (OGD) to ensure robust ANDAs.
At the conclusion of the course, students will be familiar with US regulations relating to the generics marketing application processes, and will be versant in the terms used in the regulatory affairs space.
The itemized course objectives are:
- Review of NDA approval process as basis to an ANDA submission
- Review of patent, data and marketing exclusivity in relation to ANDA submissions
- Hatch-Waxman and the patent certification requirement, including biosimilars (biologics)
- Patent Certification and Legal Actions thereof
- Elements of an ANDA submission (module 2 and 3)
- Submission requirements worldwide contrasted to the US requirements
- Clinical trial requirements to establish bioequivalence and biowaivers in lieu of performing clinical trials
- Submission and the FDA OGD Review process, OGD Review concerns and impact on ANDA approvals
- Marketing exclusivity benefits of first ANDA approval
- Post-Approval requirements for support of ANDA once approved