Elaine Hu Cunningham
Director, Promotional Regulatory Affairs @ AstraZeneca
About
Regulatory expert with over 26 years of experience in regulatory practice, policies, and procedures in the Food and Drug Administration’s Division of User Fee Management, Office of Prescription Drug Promotion, and Office of Generic Drugs; and in the pharmaceutical industry.
United States
Silver Spring
Biotechnology
Regulatory Requirements, Policy Development, Advertising/Promotion Regulatory Review , Project Management, U.S. Food and Drug Administration (FDA), Regulatory Policy, Regulatory Analysis, Regulatory Compliance, Pharmaceutical Industry, Government, Regulatory Affairs, Clinical Trials, Regulatory Submissions, Infectious Diseases, Clinical Development, Clinical Research, Lifesciences, FDA
Experience
Director, Promotional Regulatory Affairs
AstraZeneca
Director, Regulatory Affairs, Advertising and Promotion
Kite Pharma
United States
Provided regulatory leadership and strategy for promotional activities and corporate communications related to chimeric antigen receptor (CAR) T-cell therapies and pipeline products to meet commercial needs while ensuring compliance with the Federal Food, Drug, and Cosmetic Act (FD&C Act) and applicable regulations.
Retired
Commissioned Corps of the U.S. Public Health Service
Lead Regulatory Counsel / Policy Team Leader
FDA
Silver Spring, Maryland, United States
Led a team of attorneys and policy analysts in the Division of User Fee Management in the implementation and execution of five major user fee programs under the Federal Food, Drug, and Cosmetic Act for prescription drugs, generic drugs, biosimilars, over-the-counter monograph drugs, and compounded drugs that are authorized to collect over $1.9 billion annually for Agency resources necessary to facilitate the human drug review and approval process; served as the lead regulatory advisor for 65 Division managers and staff on complex scientific and legal user fee issues
Senior Program Manager
FDA
Silver Spring, Maryland, United States
Served as an Agency and external stakeholder Point of Contact in the Division of User Fee Management on a wide range or regulatory issues regarding the implementation of the Prescription Drug User Fee Act (PDUFA) under the Federal Food, Drug, and Cosmetic Act
Director Regulatory Research Officer
FDA
Silver Spring, Maryland, United States
Managed the Evidence Review Program in the Office of Prescription Drug Promotion (OPDP), providing regulatory oversight of patient-focused outcome measures, health care economic information (HCEI), subjective assessments of patients' convenience or ease-of-use with drug treatment, and drug utilization data relating to prescription drug promotion across all therapeutic categories
Senior Supervisory Regulatory Review Officer
FDA
Silver Spring, Maryland, United States
Supervised a team of four Regulatory Review Officers in the Office of Prescription Drug Promotion (OPDP) in the evaluation of prescription drug promotional materials directed to health care professionals for metabolic and endocrine, analgesic, anesthetic, substances of abuse, rheumatology, gastroenterology, pulmonary, and allergy drug products
Senior Regulatory Review Officer
FDA
Silver Spring, Maryland, United States
Served as a subject matter expert in the Office of Prescription Drug Promotion (OPDP) for patient-focused outcome measures, health care economic information (HCEI), subjective assessments of patients' convenience or ease-of-use with drug treatment, and drug utilization data in prescription drug promotion across all therapeutic categories
Regulatory Project Manager
FDA
Rockville, Maryland, United States
Supported the Division of Chemistry in the Office of Generic Drugs (OGD) to improve timeliness and review efficiency of abbreviated new drug application (ANDA) reviews
Regulatory Project Manager
FDA
Rockville, Maryland, United States
Supported the Division of Bioequivalence in the Office of Generic Drugs (OGD) to improve timeliness and review efficiency of abbreviated new drug application (ANDA) reviews
Education
University of Maryland School of Pharmacy
Pharmacy Administration and Pharmacy Policy and Regulatory Affairs
Rutgers University
Pharmacy
Elaine Hu Cunningham's Contact Information
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