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Mr. Phillips retired from the U.S. Public Health Service at the Food and Drug Administration (FDA) in 2004, after 16 years with the Agency. Joining the Agency in 1988, he became the Director of the Division of Labeling and Program Support in the Office of Generic Drugs, where he shared responsibility for the approval of all generic drugs in the U.S. In particular, he developed his expertise in the labeling and safe use of pharmaceutical products. In December of 1998, he became the Associate Director for Medication Error Prevention in the newly created Office of Post-Marketing Drug Risk Assessment (OPDRA), which is now known as the Office of Drug Safety (ODS). During his 6 years with ODS, he created and became the Acting Director of the Division of Medication Errors and Technical Support (DMETS), responsible for the review and analysis of all proprietary names in the United States. While with the ODS, he developed the methodology that the FDA uses in testing all U.S. proprietary names for safe use.
Jerry Phillips, R.Ph.
President & CEO
 

The Drug Safety Institute (DSI), a subsidiary of Brand Institute, was created in 2004. DSI is dedicated to improving the safe use of Pharmaceuticals by providing a global, state-of-the-art, research model for proprietary (brand and line extension) and nonproprietary (USAN/INN) nomenclature research. In addition, DSI offers a medication error prevention analysis associated with labeling of pharmaceuticals, biological products and medical devices. DSI also offers various risk management strategies to our clients.

Drug Safety Institute Services

STRATEGY

USAN / INN / STEM / CLASS NAME

NAME SAFETY RESEARCH

GAP ANALYSIS

REGULATORY STRATEGY CONSULTS AND REBUTTAL

NAME SAFETY REPORTS / SUBMISSION

PROMOTIONAL / ADVERTISING RESEARCH

FAILURE MODE AND EFFECTS ANALYSIS

RISK MANAGEMENT PLANS

PRODUCT LABELING, PACKAGING AND TRADE DRESS RESEARCH

REGULATORY / SAFETY REVIEW OF CONTAINER AND CARTON LABELS AND PACKAGING

NONPROPRIETARY (USAN / INN) NAME RESEARCH

At DSI our plan is to make the Brand Institute methodology for proprietary and non proprietary name safety testing even more reflective of the FDA and other regulatory agencies’ review processes.

Who is Brand Institute?

Who is Research Solutions Institute?
 

 
     
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