U.S. Marketing Applications for New Drugs, Biologics, and Medical Devices
PHAR 6130E
4 hours
U.S. Marketing Applications for New Drugs, Biologics, and Medical Devices
Course Description
Theory and practical considerations associated with preparing
new medical product applications with a focus on the
regulations that govern specific applications and
strategic/tactical issues to consider.
Athena Title
U.S. Marketing Applications
Non-Traditional Format
This course will be taught 95% or more online.
Prerequisite
[(PHAR 6010 or PHAR 6010E) and (PHAR 6020 or PHAR 6020E) and (PHAR 6030 or PHAR 6030E)] or permission of department
Grading System
A - F (Traditional)
Student learning Outcomes
Students will apply established principles of process and regulations that the FDA uses in regulating new medical product marketing applications.
Students will describe the different new product submission requirements for drugs, biologics, and medical devices.
Students will describe the critical parameters the agency uses for submission decisions.
Students will identify the organizational location of different centers and/or offices within the FDA that are responsible for reviewing new product marketing applications.
Students will develop a plan and outline for a new product submission for a new drug, biologic, and/or medical device product.
Students will write a draft submission protocol.
Topical Outline
Overview of the FDA's Investigational New Drug (IND) Program and New Drug Application Submissions
Protocols for Proposed Clinical Studies
Pathways to Market
Market Approval Applications for Biologics
Market Approval Applications for Devices Submissions
