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Expert in OTC Drugs, Generic Drugs, New Drugs and General Drug Regulations and FDA Requirements
Available for your Consulting and Expert Witness Needs
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Summary of Expertise:
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Listed with other top experts in: |
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During his tenure with FDA since 1991, Expert served in the Policy and Guidance Branch of the Center for Drug Evaluation and Research (CDER) with responsibility for the development and interpretation of the Current Good Manufacturing Practice Regulations for Pharmaceuticals and the development of compliance policy guides, inspection guides and guidelines regarding pharmaceutical manufacturing.
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Most recently with the FDA he served as the official liaison between CDER and the United States Pharmacopeial Convention, Inc. (USPC). There he was responsible for the management and assessment of all USPC compendial revisions on approved and pending drug applications; the certification of all insulin products marketed in the U.S.; and the evaluation of stability data for shelf life extension studies conducted for the Department of Defense.
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Expert worked for the FDA for 30 years. He began as a pharmacist with the U.S. Public Health Service and served at several hospitals and medical clinics throughout the country. In 1981 he was assigned to the headquarters office in Rockville, Maryland and served in a variety of pharmacies and health resource and service oriented positions.
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Show Secondary and Basic Areas of Expertise | Localities:
Expert may consult nationally and internationally, and is also local to the following cities: Baltimore, Maryland;
Frederick, Maryland;
Gaithersburg, Maryland;
Bowie, Maryland;
Richmond, Virginia;
Alexandria, Virginia;
Wilmington, Delaware;
and Lancaster, Pennsylvania.
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Degree |
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Subject |
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Institution |
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1975
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M.P.H.
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Health Services Administration and Planning
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University of Hawaii, School of Public Health
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1965
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P.D. and B.S.
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Pharmacy
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University of Maryland, School of Pharmacy
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| Years |
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Employer |
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Department |
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Title |
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Responsibilities |
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1995 to
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Expert's Firm
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Senior Consultant
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Expert advices clients on matters of OTC drugs, generic drugs, new drugs, and FDA regulations.
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1993 to 1995
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Center for Drug Evaluation and Research
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Compendial Operations Branch
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Chief
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He was the official liaison between the U.S. Pharmacopeial Convention, Inc. and Center for Drug Evaluation and Research.
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1991 to 1993
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Center for Drug Evaluation and Research
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Policy and Guidance Branch, Division of Manufacturing
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Director, Health Promotion Officer, Consumer Safety Officer
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His primary responsibility was the development of agency policy regarding pharmaceutical manufacturing compliance, reviews of foreign firms, and communication with the bilateral countries.
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1989 to 1991
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HRSA - Office of Health Facilities
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Division of Facilities Loans
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Director
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Expert administered the loan facility monitoring responsibilities to all health facilities with direct and guaranteed Hill-Burton loans and Department of Housing and Urban Development mortgage insurance for hospitals. He supervised a staff of 23 professionals and support personnel in the central office and had operational responsibility for personnel in the ten regional offices.
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1986 to 1989
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HRSA - Bureau of Resources Development
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Division of Facilities Assistance and Recovery
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Director
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Expert directed a national program to assure the provision of federal assistance for medical services to eligible beneficiaries under Title VI-VIII and XVI of the PHS Act. With a staff of 18 professionals, he actively monitored 5,900 facilities with grants amounting to $4.7 billion.
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1985 to 1986
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HRSA - Bureau of Health Maintenance Organizations and Resources Development
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Division of Facilities Resources
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Deputy Director
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He shared responsibility for the direction of the Division's programs and 20 personnel. The Division had responsibility for the analyses and collection of an information base on the health care industry.
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1983 to 1985
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HRSA - Bureau of Health Care Delivery and Assistance
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Division of Primary Care Services
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Chief, Pharmacy Officer
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Expert developed bureau-wide programs and policies. He was responsible for the implementation of pharmacy, as well as other clinical programs, within the Division to assure the organized delivery of health care services at the over 600 community and migrant health care managed facilities by the Division.
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1982 to 1983
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HRSA - Bureau of Health Care Delivery and Assistance
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Division of Beneficiary Medical Programs
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Associate Director for Operations
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He was responsible for the administration of a nationwide medical care program for approximately 46,000 eligible beneficiaries, employing a staff of 28 with an annual operating budget of over $20 million dollars.
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Associations/Societies
Expert is a member of the Maryland Pharmaceutical Association, the American Society of Health Systems Pharmacists, the Association of Military Surgeons of the United States, the Commissioned Officers Association of the United States Public Health Service (USPHS), and the Federal Health Care Executives Institute Alumni.
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Awards/Recognition
Expert has received the following awards: Surgeon General's Exemplary Service Medal (1995); Meritorious Service Medal (1989); Commendation Medal (1983, 1991); Public Health Service Citation (1981, 1987); Outstanding Unit Citation (1985, 1988); Unit Citation (1981, 1982, 1984, 1989); and the Bureau of Medical Services Director's Award (1982).
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Publications and Patents Summary
Expert has published and presented ten papers at conferences.
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Selected Publications and Publishers
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- Philadelphia Pharmaceutical Forum, AAPS
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- Society of FDA Pharmacists
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- American Association of Pharmaceutical Scientists
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- United States Public Health Service
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- Chemical Specialties USA Symposium
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| Government Experience: |
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Role |
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Description |
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Food and Drug Administration (FDA)
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Various
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Expert worked for the FDA in various capacities for 30 years.
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Recent Client Requests:
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Otc drug expert for consulting on OTC cold sore med requirements.
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Click the green button above to contact
Expert for a free initial screening call regarding your expert consulting needs.
Expert is available for consulting to corporate, legal and government clients.
Remember, your initial screening call to speak with
Expert is free.
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Recent Litigation Client Requests:
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FDA expert needed for consulting regarding FDA regulation needed for ongoing litigation.
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Pharmaceutical manufacturing expert to evaluate manufacturing process and CGMP issues related to a pharmaceutical company's production of a double dosage of certain drugs.
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FDA warning expert testimony for consulting on generic prescription drug warnings; compliance with FDA standards of package insert warning; dear doctor warning letters.
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FDA expert witness for consulting on an atypical antipsychotic..
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Click the green button above to contact
Expert for a free initial screening call regarding expert testimony,
litigation consulting and support, forensic services, or any related expert witness services.
A few litigation needs include product liability, personal injury, economic loss, intellectual property
(patent, trademark, trade secret, copyright), and insurance matters. Remember, your initial screening
call to speak with
Expert is free.
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| International Experience: |
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Summary |
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Europe
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He has traveled throughout Europe performing cGMP compliance audits.
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| Additional Skills and Services: |
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Training/Seminars
He has taught a FDA national training course during an orientation to international inspections titled “Inspection of Bulk Drug Facilities.”
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Education
