Amarin Corp Plc (AMRN)

[Biobillionair]

Louie,
What's you read on CDER's reorg January 2016?

http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ucm418347.htm

Office of Pharmaceutical Quality
CDER’s Office of Pharmaceutical Quality’s (OPQ) mission is to assure that quality medicines are available for the American public.

What OPQ Does
OPQ is a new office within CDER that creates a single unit dedicated to product quality. The new structure, to be stood-up in January 2015, is expected to provide better alignment among all drug quality functions at CDER, including review, inspection, and research.

OPQ will combine non-enforcement-related drug quality work into one super-office, creating one quality voice and improving our oversight of quality throughout the lifecycle of a drug product. OPQ creates a uniform drug quality program across all sites of manufacture, whether domestic or foreign, and across all drug product areas – new drugs, generic drugs, and over-the-counter drugs.

This organizational structure, along with new processes and policies, will support our mission to ensure that safe, effective, high quality drugs are available for the American public.

Changes include:

•Realignment of functions and personnel from the Office of Pharmaceutical Science to OPQ
•Realignment of preapproval and surveillance inspection activities from the Office of Compliance (OC) to OPQ
•Realignment of inspection-related activities for bioequivalence/bioavailability and non-clinical studies from OC’s Office of Scientific Investigations to the Office of Translational Sciences
Office of Pharmaceutical Quality Offices and Leadership
The following individuals will begin serving in January, 2015:

Acting Director: Janet Woodcock, M.D.
Deputy Director: Lawrence Yu, Ph.D.

•Office of Program and Regulatory Operations (OPRO): Giuseppe Randazzo (Acting)
•Office of Policy for Pharmaceutical Quality (OPPQ): Ashley Boam (Acting)
•Office of Biotechnology Products (OBP): Director: Steve Kozlowski
•Office of New Drug Products (ONDP): Sarah Pope Miksinski (Acting)
•Office of Lifecycle Drug Products (OLDP): Susan Rosencrance (Acting)
•Office of Testing and Research (OTR): Lucinda (Cindy) Buhse (Acting)
•Office of Process and Facilities (OPF): Christine Moore (Acting)
•Office of Surveillance (OS): Theresa Mullin (Acting)


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