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February 08, 2016 3:23 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: 60
Associate Commissioner for Policy and Planning
Director of New Psychiatry Products Division
Principal Deputy Commissioner and Chief Scientist
Deputy Commissioner of Foods
Compensation as of Fiscal Year 2015.

United States Food and Drug Administration Key Developments

Food and Drug Administration Issues Guidance for Industry on Postmarketing Adverse Event Reporting

Food and Drug Administration, Department of Health and Human Services, has issued a notice called: Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Guidance for Industry on Postmarketing Adverse Event Reporting for Nonprescription Human Drug Products Marketed Without an Approved Application. The Food and Drug Administration (FDA) is announcing that a collection of information entitled 'Guidance for Industry on Postmarketing Adverse Event Reporting for Nonprescription Human Drug Products Marketed Without an Approved Application' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

United State Food and Drug Administration Approves Waiver of New Drug Application Filing Fee for Elite Pharmaceuticals, Inc

The United State Food and Drug Administration granted Elite Pharmaceuticals, Inc. a waiver of the application fee required for the filing of a New Drug Application (NDA). Under section 736(d)(1)(E) of the Federal Food, Drug and Cosmetic Act the FDA may grant a waiver of the $2,335,200 NDA application fee for the first human drug application that a small business submits for review. Elite will immediately submit a 505(b)(2) New Drug Application for its lead opioid abuse-deterrent candidate ELI-200, immediate-release Oxycodone Hydrochloride 5mg, 10mg, 15 mg, 20 mg and 30mg capsules with sequestered Naltrexone Hydrochloride, for the treatment of moderate to severe pain with the United States Food and Drug Administration. FDA notification regarding acceptance of the submission for review is expected to take 6 to 12 weeks.

Food and Drug Administration and Department of Health and Human Services Issue Final Order on Completion of Product Development Protocol for Surgical Mesh for Transvaginal Pelvic Organ Prolapse Repair

Food and Drug Administration (FDA), Department of Health And Human Services (HHS), has issued a final order called: Effective Date of Requirement for Premarket Approval for Surgical Mesh for Transvaginal Pelvic Organ Prolapse Repair. The final order, published in the Federal Register on Jan. 5 by Leslie Kux, Associate Commissioner for Policy, states: The Food and Drug Administration (FDA or the Agency) is issuing a final order to require the filing of a premarket approval application (PMA) or notice of completion of a product development protocol (PDP) for surgical mesh for transvaginal pelvic organ prolapse (POP) repair.

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