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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
http://www.hpm.com

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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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The Medical Device Amendments of 1976: The Statute That Went Awry
Jeffrey K. Shapiro, June 5, 2013
The Medical Device Amendments of 1976 (“MDA”), Pub. L. No. 94-295, 90 Stat. 539 (1976), are commonly described as the beginning of the modern era of device regulation. In one sense, this description is absolutely correct. The MDA established for the first time a comprehensive scheme for...

2015 Dietary Guidelines Deliberations Get Underway
Ricardo Carvajal, June 4, 2013
DHHS and USDA announced the inaugural meeting of the 2015 Dietary Guidelines Advisory Committee (DGAC), scheduled for June 13-14. At the inaugural meeting, the DGAC will be provided with an orientation to the process for revising the Dietary Guidelines (revisions take place every five years) and...

Bayer Joins the Combo Drug NCE Challenge Club; Petitions FDA for 5-Year Exclusivity for NATAZIA
Kurt R. Karst, May 31, 2013
For the third time this year, FDA has been asked to recognize 5-year New Chemical Entity (“NCE”) exclusivity for a fixed-dose combination drug product containing both a never-before-approved active moiety and a previously approved active moiety. In a Citizen Petition (Docket No....




Year Established: 1980


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