For Assignment #1, students will have the opportunity to work in teams to construct a 1200-1500 word research paper on an emerging product. Teams are to propose a new biomedical product and identify the regulatory strategy to gain FDA approval of that product. Each paper shall include (at minimum) the type of product, issues related to regulatory approval of the product, and a proposed pathway for approval, including types of studies required. Include any recommendations for meetings with rationale (see example below).

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Formatting: Students are required to use 12-point, Arial font type; double-spaced; 1 inch margins.

Turnitin: Students have two opportunities for submission. A score of 30% or higher will not be accepted.

References: ALL References utilized to develop the the research paper must be listed on a final separate page of the assignment. APA style referencing is required for all course assignments.

Grading: Students are required to submit the final product using the available link by the stated deadline. A 20% per day deduction will be applied by the instructor for late assignments. Assignments submitted more than 2 days past the deadline will not be accepted. Students will receive an email from the instructor once grades and feedback are available.