1. Assume that you are a Regulatory Affairs Associate and the company that you work for
is developing a combination product. Your employer has requested that you gather the
information needed to submit a Request for Designation (RFD) by the FDA.
A. What is an RFD (Request for Designation) of Combination Products and why is one
2. Some challenges with determining the PMOA (Primary Mode of Action) are that the
combination product is still in early development or that the combo product may have
two completely different modes of action and neither is subordinate to the other.
A. Define PMOA
B. Discuss those challenges.
This paper should be at least 1 double spaced page in length, not including title or reference
pages. (No abstract is needed.) Make sure the paper is AMA format with double-spacing, Times
New Roman, 12-point font, and 1” margins. Include citations and a list of references in AMA
(American Medical Association) format utilizing at least 4 resources. Edit for spelling and