Biotech Values

[DewDiligence]

Good news for generic-drug companies (maybe):

http://www.raps.org/regulatory-focus/news/2014/07/19794/FDA-Announces-New-Leadership-for-OGD-Super-Office/

The US Food and Drug Administration's long-awaited reorganization of its Office of Generic Drugs (OGD) is finally getting underway, the agency said in a statement today.

Since late 2012, FDA has been planning to elevate OGD to a so-called "Super Office"—an office which reports directly to the director of the Center for Drug Evaluation and Research, a position now held by longtime Director Janet Woodcock.

…FDA has announced that it has filled…four [OGD] offices with new leaders:

• Rob Lionberger, now acting deputy director for science, will lead the Office of Research and Standards (ORS), which includes the Division of Therapeutic Performance and the Division of Quantitative Methods and Modeling.

• John Peters, now a supervisory medical officer, will lead the Office of Bioequivalence (OB), which includes the three Divisions of Bioequivalence and the Division of Clinical Review.

• Jason Woo, now the implementation manager for the Generic Drug User Fee Act (GDUFA), will lead the Office of Regulatory Operations (ORO), which includes the Division of Filing Review, the Division of Labeling Review, the Division of Project Management, and the Division of Quality Management Systems.

• Keith Flanagan, regulatory counsel at OGD, will remain as transition lead for the Office of Generic Drug Policy (OGDP), which includes the Division of Policy Development and the Division of Legal and Regulatory Support.
…In a statement emailed to FDA staff, Woodcock conceded that the OGD reorganization had been a "long and arduous task" thus far, but that the benefits of the reorganization would benefit both FDA and the public in the coming years.

"The new structure will allow the Agency to conduct reviews of generic applications in a much more timely and effective manner while meeting GDUFA goals that become more rigorous and challenging each year," Woodcock wrote.