Office of Regulatory Affairs (ORA)

FLC Region

Security Lab

No

Address

109903 New Hampshire Avenue
Silver Spring, MD 20993
United States

Description

Regulatory science employs previously validated and well-characterized methods to analytically uncover non-compliances with a specific set of established regulations. Regulatory science has to conform to certain principles such that analytical results produced are accurate, reproducible, and defensible in a court of law. These principles include choice of appropriate methods fit for use, thorough characterization and validation of those methods, proper implementation of the methods using the right instrument and the right analyst with the right proficiency, careful data analysis and reporting.

Mission

ORA’s core mission is to preserve the regulatory value of the scientific work conducted in its laboratories. A strong foundation of regulatory science leads to swift, decisive enforcement action and allows the agency to quickly refute any legal challenges brought against its findings.

In addition to performing compliance testing on a wide variety of FDA-regulated products, ORA laboratories also maintain an active research program anticipating future areas of programmatic work and developing methods to meet emerging agency needs. ORA annually spends 10 – 15 million US dollars to equip its laboratories with cutting edge technology. Maintaining investigative research within its laboratories and balancing this work with the compliance work that is performed is a priority for ORA. This mode of operation keeps the ORA laboratories engaged in analytical thinking and allows them to retain/improve their problem-solving skills.

Technology Disciplines

Technologies
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A Hand Held Portable Device Based on Light Emitting Diodes (LEDs) as a Light Source for Use in the Detection of Counterfeit Pharmaceutical Drugs and Packaging
Facilities
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Arkansas Regional Lab (ARL)
Denver Laboratory
Detroit Laboratory
Forensic Chemistry Center (FCC)
Kansas City Laboratory
Northeast Regional Lab (NRL)
Pacific Regional Lab Northwest (PRL-NW)
Pacific Regional Lab Southwest (PRL-SW)
Philadelphia Laboratory
San Francisco District Laboratory (SAN)

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