Policy analysis of foreign trials needed for FDA-approved INDs for devices and drugs from 2016 to 2020

<p>Any new drug or medical device requires testing before it can be commercialized. Although there are many paths a product can follow during preclinical testing to bringing it to the market, the need for multinational data is more necessary for drugs in comparison to medical devices. Since drugs do not always need additional data, there is a need to investigate why medical devices are more easily approved than drugs. The use of foreign data is fairly recent, and even though there are advantages to executing clinical trials in foreign countries, some companies do not want to run their studies outside the US. For this study, approved drugs and medical devices were taken from clinicaltrials.gov and the FDA’s website from the years 2016 to 2020 to show the relationship of medical devices approved without the use of multinational data compared to drugs. Although there were more medical devices approved by the FDA without the use of foreign data, the impact of foreign clinical trial data needed for drug and medical device approval long term remains unknown.</p>

Name thesis:degree_name

Master of Science (MS)

Level thesis:degree_level

Open Access Thesis

Discipline thesis:degree_discipline

Health Sciences

Year dc:date.available

2022

Author dc:creator

• Tilley, Rebekah

Contributors dc:contributor

• Michael Switzer, PhD, Chair
• Jean Rowan, MD, MS

• Health and Medical Administration

Repository record dc:identifier

https://commons.emich.edu/theses/1163

OAI identifier oai:identifier

oai:commons.emich.edu:theses-2536