Practice Areas ; Food, Drug and Cosmetic Law(25%)&sa=270&d=1&h=180&w=200&sl=false&dm=True&in=50) | |
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| Contact Info | Telephone: 202-778-2265 Cell Phone: 410-961-7582 Fax: 202-778-7425 http://www.hunton.com/bios/bio.aspx?id=17816&tab=0013
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| University | Temple University (B.A., 1975; M.A., 1980; Ph.D., 1984) |
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| Law School | Georgetown University Law Center, J.D., cum laude, 1991 |
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| Admitted | 1992, Maryland; 1994, District of Columbia; U.S. District Court, District of Maryland; U.S. Court of Appeals, Baltimore County Circuit |
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| Memberships | Maryland State and American Bar Associations; The District of Columbia Bar. |
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| Born | Philadelphia, Pennsylvania |
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| Biography | Recipient, E. Randolph Williams Pro Bono award, 2008. Member, Society for Clinical Trials. Associate Professor, Family Medicine and Epidemiology and Preventive Medicine, U. Maryland. Director of Research, U. Maryland Center for Integrative Medicine (2003-2006). Faculty, (1993-2003) and Adjunct Associate Professor (2003-2007), Center for Clinical Trials, Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health. Prior Deputy Director, NIH-funded Sleep Heart Health Study Coordinating Center and Director, A+ Asthma Early Intervention Headstart Trial Coordinating Center. Design and implementation of multi-center clinical trials, including the National Eye Institute-funded "Studies of Ocular Complications of AIDS" trials - testing the efficacy of therapies for cytomegalovirus retinitis in people with AIDS (1993-2003). Chairperson, Data and Safety Monitoring Board, NIH-funded placebo controlled "Clinical Trial of Lorenzo's Oil in AMN". Member, Data and Safety Monitoring Board, completed NIH-funded "Restorative Care Study". Member: Institutional Review Board, Maryland Medical Research Institute; Human Rights Committee, Veteran's Affairs Cooperative Studies Program Coordinating Center at Perry Point. Coursemaster, "Design and Conduct of Clinical Trials," Johns Hopkins School of Public Health (1998-2003). NIH grants applications peer reviewer. Biomedical journals peer reviewer for Annals of Epidemiology, Journal of the American Medical Association, Clinical Journal of Pain, and Annals of Internal Medicine. Named in top 10% of peer reviewers by Annals of Internal Medicine (2005).
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| ISLN | 900898288 |
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Documents by this lawyer on Martindale.com | |
FDA Issues Three Draft Guidances on Biosimilar Product DevelopmentHeather D. Banuelos,Adele M.K. Gilpin,Gary C. Messplay,Allison Reschovsky,Brian J. Wesoloski, February 16, 2012 On February 9, 2012, the U.S. Food and Drug Administration (“FDA” or “the Agency”) issued the following three draft guidance documents to assist industry in developing biosimilar products: |
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