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  1. Regulatory News, Stories, and Features

ORA Feature Stories

To illustrate the unique value of ORA's regulatory investments we have developed a series of feature stories that describe recent advances by our colleagues and their impacts on public health.

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Patient Advocacy Lies at Heart of FDA Agent’s Theranos Case

By: Pat El-Hinnawy and Erin Peabody

As patients seek legal recourse for harms they suffered at the hands of fraudulent start-up Theranos, there’s one FDA criminal investigator who understands their pain—perhaps better than anyone. 


University of Michigan School of Pharmacy students with chemist Michael Truchan at ORA's Detroit Medical Products Laboratory

ORA's Detroit Laboratory and University of Michigan Students Connect for Lab Tour

By Dawn Pyant

“Science is the universal language,” said Jeanpaul Mivoyel, Acting Director of ORA's Detroit Medical Products Laboratory (DETLMP), a remark that spoke volumes to a visiting group of students from the University of Michigan (U-M), there to participate in a presentation and tour of the laboratory. 



Diane Gowned in Cleanroom for Sterility Testing of Bandages Insulin Syringes

Of Bacteria and Bad Actors

FDA scientists, like Diane Biron, must battle both to ensure the safety of America’s medical devices. 


 

Photo of Winchester Engineering Analytical Center (WEAC)

FDA lead laboratory for medical device and radioanalytical testing

The Winchester Engineering and Analytical Center (WEAC) is the only FDA facility that performs analyses of medical devices, such as CT scanners, pacemakers, and defibrillators. Learn more about the WEAC facility by reviewing the  https://youtu.be/TOCop47Dwew and the WEAC web page



San Juan-based Public Affairs Specialist Janice Lopez Munoz

Public Outreach Remains Powerful Agency Tool

For more than 70 decades, FDA's public health educators work to protect Americans from false and misleading information. 
 


New York State Department of Agriculture and Markets Commissioner Richard Ball and FDA Commissioner Robert Califf sign

New York State Formalizes Food Safety Efforts with the FDA

The agency signs a domestic mutual reliance partnership agreement with the New York Department of Agriculture and Markets. 


Photo of FDA Chemist

All Hands on Safety

The agency’s tireless and, at times, technical battle during the pandemic to protect Americans from unsafe hand sanitizers


Photo showing two FDA staff during a fish inspection

Scrutiny and Safety at Toyosu Market

ORA investigator Derek Dealy shares how his discovery at the famous Japanese market protected public health and, personally, affirmed his choice of career. 


 

 

 

 

 

 

 

 

 

 

 
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