Medical Device Food

JULIAN KLAZKIN

**** ******* ***** ****: 301-***-**** Bethesda, Maryland 20814 Cell: 240-***-****

e-mail : ******@*****.***

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LEGAL EXPERIENCE

September 1982- Senior Attorney, U.S. Government Accountability Office (GAO)

July 2011 Washington, DC

• Advisor to the Comptroller General, the General Counsel and GAO auditors on various legal, legislative, and regulatory matters. Specializing in food, drug and medical device issues including:

Drugs: drug safety, imports, pipeline drugs, internet pharmacies, Plan B, development of taxol, pharmacy compounding, pediatric drug and other marketing exclusivities , DTC ads, orphan drugs, PDUFA, GMPs, human subject protection, adverse event reporting

Devices: MDUFMA, accredited inspectors, MDR, GMPs, 510(k)s and premarket approval, regulation of heart pacemakers, TMJ devices, pediatric devices, single-use devices

Food: recalls, dietary supplements, ephedra, antibiotic resistance in animals, food inspection, fluoridation, food additives, food labeling

PUBLICATIONS Food and Drug Law Institute, “Update” Magazine, May/June 2007, “Therapeutic Orphans No More: FDA and Congressional Efforts to Encourage the Study of Drugs in Children”

EDUCATION

May 1982 Juris Doctor, Catholic University of America

The Columbus School of Law, Washington, D.C.

May 1977 Master of Science in Journalism, Northwestern University

Medill School of Journalism, Evanston, Illinois.

May 1974 Bachelor of Arts in History, Magna Cum Laude

State University of New York at Buffalo

Phi Beta Kappa

MEMBERSHIPS District of Columbia Bar

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