FDA Amendment Act

Date: July 28 2021

Summary: How the FDA addressed concerns about drug recalls

Keywords: #food #drug #administration #omop #act #congress #sentinel #initiative #archive

Bibliography

EHDEN Academy

Table of Contents

• FDA thought clinical trials for drug testing was:

- Too short
- Too small scale

• FDA requested observational testing of released drugs based on actual patients

• US Congress passed the FDA Amendment Act

- Establishing a Risk Identification and Analysis System
	- Framework to generate evidence to characterise any possible effects from drugs in use
	- Utilizes observational healthcare data sources
- Sentinel Initiative created by FDA
	- Surveys and studies effects of drugs on patients

• Lack of regulation and drug approval guidelines after decision

- Required industry partnerships 
- Culminated in the creation of the [Observational Medical Outcomes Partnership (OMOP)](https://jacobzelko.com/07282021181744-origins-omop)

How To Cite

Zelko, Jacob. FDA Amendment Act. https://jacobzelko.com/07282021175202-fda-risk-prevention. July 28 2021.

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