September 30, 2014 10:20 AM 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
Chief Medical Officer
Compensation as of Fiscal Year 2014.

United States Food and Drug Administration Key Developments

United States Food and Drug Administration Presents at BIOWEST Conference 2014, Sep-10-2014 04:45 PM

United States Food and Drug Administration Presents at BIOWEST Conference 2014, Sep-10-2014 04:45 PM. Venue: Marriot City Center, Denver, Colorado, United States. Speakers: Margaret A. Hamburg, Commissioner.

Judge Ketanji Brown Jackson of the United States District Court Grants Depomed, Inc.'s Motion for Summary Judgment

On September 5, 2014, Judge Ketanji Brown Jackson of the United States District Court for the District of Columbia granted Depomed Inc.'s motion for summary judgment in the company's lawsuit against the United States Food and Drug Administration (the FDA) seeking an order requiring the FDA to grant Gralise (gabapentin) Orphan Drug exclusivity for the management of postherpetic neuralgia (PHN). The court's ruling requires that the FDA grant Orphan Drug exclusivity for Gralise for the management of PHN. The court's ruling requires that the FDA grant Orphan Drug exclusivity for Gralise for the management of PHN.

Masimo Corporation Receives Warning Letter from U.S. Food and Drug Administration

On August 14, 2014, Masimo Corporation received a warning letter from the U.S. Food and Drug Administration (FDA) regarding compliance with current Good Manufacturing Practices at Masimo's Irvine, California manufacturing facility. The Warning Letter follows an FDA inspection that concluded in October 2013. As previously disclosed, at the conclusion of that inspection, the FDA issued Masimo a Form 483 Inspectional Observations (the Form 483). Masimo responded to the Form 483 and provided information to the FDA in October and December 2013. The Warning Letter does not identify any new observations that were not included in the Form 483. Masimo takes the matters identified in the Warning Letter seriously and is in the process of evaluating what corrective actions, and associated costs, may be required to address the matters raised in the Warning Letter. Masimo is also in the process of preparing a response to the Warning Letter and intends to respond fully to the issues raised by the FDA within 15 business days as requested by the FDA and to work expeditiously to address those issues. The Warning Letter does not restrict the manufacture, production or shipment of any of Masimo's devices, nor require the withdrawal of any product from the marketplace. Masimo will diligently work with the FDA to resolve the issues raised in the Warning Letter. However, failure to promptly address the issues raised in the Warning Letter to the FDA's satisfaction or to comply with U.S. medical device regulatory requirements in general could result in regulatory action being initiated by the FDA. These actions could include, among other things, product seizures, injunctions and civil money penalties.

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