February 01, 2015 12:15 PM ET

Company Overview of United States Food and Drug Administration

Company Overview

158-15 Liberty Avenue

Jamaica, NY 

United States

Phone:

7183407006

Key Executives for United States Food and Drug Administration

Commissioner
Age: 59
Deputy Commissioner for Operations and Chief Operating Officer
Associate Commissioner for Policy and Planning
Director of New Psychiatry Products Division
Principal Deputy Commissioner and Chief Scientist
Compensation as of Fiscal Year 2014.

United States Food and Drug Administration Key Developments

US FDA Establishes Office of Pharmaceutical Quality; Janet Woodcock to Serve as Acting Director

The US FDA has announced the launch of the newly created Office of Pharmaceutical Quality (OPQ) that will focus on streamlining quality control at pharmaceutical manufacturing facilities. The director of the FDA's Center for Drug Evaluation and Research, Janet Woodcock, has stated that the initiative would ensure standardised quality metrics would be used for all pharmaceutical products. The OPQ will review all drug applications and will issue a manufacturing quality value to the product. The OPQ will also work with manufacturers to help address any manufacturing problems or concerns. Janet Woodcock will serve as acting director of the OPQ until a permanent director is found.

Dara Biosciences Receives Waiver of Approximately $1.1 Million for Product and Establishment Fees by the FDA

DARA BioSciences Inc. announced that it has been granted a barrier-to-innovation waiver for certain product and establishment fees. The Food and Drug Administration has granted company's request for a barrier-to-innovation waiver of the fiscal year 2012 product and establishment fees, fiscal year 2013 product fee, and fiscal year 2014 product and establishment fees for NDA, 21-807, Soltamox oral solution totaling approximately $1.1 million. A waiver or reduction in PDUFA fees may be appropriate when the product for which the waiver is being requested is innovative or the entity requesting the waiver is otherwise pursuing innovative drug products or technology, and the fee would be a significant barrier to the entity's ability to develop, manufacture, or market innovative products or technology. Specifically, the FDA acknowledged company's development work surrounding its KRN5500 asset during the years relating to the waiver, and determined that the imposition of the fees during those years created a significant financial barrier to the company. The company has requested a similar waiver for 2015. The FDA's Office of Financial Management (OFM) has been directed to refund the fees related to fiscal year 2012 already remitted by the company in the amount of approximately $619,000 which should be processed and refunded within 30 days from the waiver being granted. The fees related to fiscal years 2013 and 2014 which have not been remitted total approximately $480,000.

U.S. District Court for the District of Columbia Issues Order in Connection with Action Filed Against the Food and Drug Administration by Veloxis, Seeking an Order to Grant Final Approval to Envarsus XR

Veloxis Pharmaceuticals A/S issued the statement regarding an order issued by the U.S. District Court for the District of Columbia in connection with the action the company filed on December 16, 2014 against the Food and Drug Administration (FDA), seeking an order requiring the FDA to grant final approval to Envarsus XR. Envarsus XR is a once-daily extended-release tablet indicated for prophylaxis of organ rejection in kidney transplant patients.  Although Envarsus XR has been found to be safe and effective, FDA determined that the period of statutory exclusivity granted to another extended-release tacrolimus product, Astagraf XL, blocks Envarsus XR from being sold in the United States until that exclusivity period expires (July 2016) as previously announced by the Company on October 31, 2014. The company believes that FDA's action is contrary to the requirements of the controlling statute, its regulations and longstanding agency precedent. Its lawsuit seeks a determination by the Court that Envarsus XR should be immediately approved for sale in the United States.

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