Regulatory considerations for new drugs and devices

Haley Nadone; Christian Gonzalez; Mark Riddle

doi:10.1016/B978-0-323-90300-4.00088-4

Regulatory considerations for new drugs and devices

Haley Nadone, Christian Gonzalez, Mark Riddle

Research output: Chapter in Book/Report/Conference proceeding › Chapter › peer-review

Abstract

The US Food and Drug Administration (FDA) has metamorphosed from a small branch of the US Department of Agriculture's Office with no regulatory powers to one of the largest and most strict consumer protection agencies in the world. This creates a dichotomy between efficient regulation of medical products and keeping the public safe. To complete translational research it is essential to dissertate the regulatory considerations for new drugs and devices. This chapter will discuss what data the FDA will require, what data may be collected on nonapproved drugs and medical devices, and some issues with the FDA.

Original language	English
Title of host publication	Handbook for Designing and Conducting Clinical and Translational Surgery
Publisher	Elsevier
Pages	433-437
Number of pages	5
ISBN (Electronic)	9780323903004
DOIs	https://doi.org/10.1016/B978-0-323-90300-4.00088-4
State	Published - 1 Jan 2023
Externally published	Yes

Keywords

Animal rule
Device approval
Device classification
Drug approval
FDA
Medical device
Nonapproved device
Nonapproved drug
Patient safety

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10.1016/B978-0-323-90300-4.00088-4

Cite this

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Regulatory considerations for new drugs and devices

Abstract

Keywords

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