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  1. Regulatory News, Stories, and Features

OII Feature Stories

 

 

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

 

Photo of Rajiv Srivastava

FDA Investigator Travels Globe to Help Ensure Safety of America’s Medicines 

By: Erin Peabody

When we pick up a prescription at our local drugstore, we’re often asked by the pharmacist if we have any questions. Fortunately for Americans, FDA consumer safety officers like Rajiv Srivastava have devoted their careers to scrutinizing the safety of pharmaceutical drugs bound for the U.S. market—and travelling halfway around the world to do so. 


New York Medical Products Laboratory team

Safeguarding Communities and National Drug Stockpiles

By: Monique Richards 

ORA’s New York Medical Products Laboratory is safeguarding the health and well-being of communities by analyzing medical products for suspected health fraud and testing products for potential issues.  The office also ensures that critical drugs in the National Strategic Stockpile are safe and ready by recommending extending the expiry date of drugs tested by the FDA 


 

pseudomona aeruginosa

The Hunt for a Blinding Bacterium

By: Erin Peabody

These super strains of bacteria, viruses, and fungi can cause devastating infections, known for their genetic ability to turn on a dime, so to speak, picking up new defenses and resistances that can render even the most potent antibiotics and other drugs useless.


 

OCI badge

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 years, 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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