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Hyman, Phelps & McNamara, P.C.

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Hyman, Phelps & McNamara, P.C. 
Washington, District of Columbia Office
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700 Thirteenth Street, N.W., Suite 1200
Washington, District of Columbia  20005-5929

Telephone: 202-737-5600
Fax: 202-737-9329

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Office Hours:
Monday: 08:30 AM-06:30 PM
Tuesday: 08:30 AM-06:30 PM
Wednesday: 08:30 AM-06:30 PM
Thursday: 08:30 AM-06:30 PM
Friday: 08:30 AM-06:30 PM

About this office:

Hyman, Phelps & McNamara, P.C. is a law firm that advises and represents a broad range of clients on legal issues concerning food, drug, medical device and cosmetic law and regulation. To complement its core expertise in FDA matters, the firm also serves its clients in related areas, such as advertising, controlled substance regulation, health care fraud and abuse, reimbursement, pricing laws and government contracts. In 1980, three former U.S. Food and Drug Administration (FDA) lawyers opened the firm in Washington, D.C. to concentrate in this area of the law. Hyman, Phelps & McNamara, P.C. now has one of the most extensive food and drug practices in the United States.


Statement of Practice Summary:
Practice before all Courts, Government Agencies, International Regulatory Authorities involving Foods, Drugs, Cosmetics, Medical Devices, Biologics, Pesticides, Health Care, Controlled Substances and Consumer Products.

Documents by Lawyers at this office
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A Second Company Asks FDA to Reconsider Denial of NCE Exclusivity for Approved FDC . . . and to Stay Application of the Agency’s New Interpretation
Kurt R. Karst, April 23, 2014
The battle over New Chemical Entity (“NCE”) exclusivity for Fixed-Dose Combination (“FDC”) drugs continues to heat up. In a recent Petition for Reconsideration and Petition for Stay (Docket No. FDA-2013-P-0119), Ferring Pharmaceuticals, Inc. (“Ferring”) requestes...

Proposed GMO Labeling Bill Would Block State Laws
Riëtte van Laack, April 21, 2014
Legislation that would require labeling of genetically engineered or bioengineered foods (generally referred to as “GMOs”) has been proposed in various states. If enacted, these state laws may expose companies to a patchwork of different GMO labeling requirements.

Zogenix Prevails in Initial Challenge to Massachusetts Emergency Order Banning ZOHYDRO ER
Kurt R. Karst, April 21, 2014
When we first heard about the Complaint and Motion for Preliminary Injunction Zogenix, Inc. filed against Massachusetts Governor Deval Patrick, among others, alleging that the Commonwealth’s ban on FDA-approved ZOHYDRO ER (hydrocodone bitartrate) Extended-release Capsules is unconstitutional...

Year Established: 1980

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