Galveston National Laboratory / Novartis Pharmaceuticals / National Laboratory / /
Currency
USD / / /
Event
FDA Phase / Reorganization / Patent Issuance / /
Facility
Galveston National Laboratory / Rockville Pike / Emerging Infectious Diseases Research Facility / /
IndustryTerm
biological products / biologics license applications / study protocol / information technology / grant applications / manufacturing / human drug product / /
Organization
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration / National Institute of Health / DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Notice of Intent To Prepare / TX AGENCY / Patent and Trademark Office / office of Regulatory Affairs / Division of Dockets Management / DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Submission / Availability AGENCY / FDA / office of Management and Budget / Center for Drug Evaluation and Research / Department of Health and Human Services / Center for Biologics Evaluation and Research / /
Person
Brent Stanfield / Jeffrey Shuren / Jane A. Axelrad / Karl F. Malik / / /
Position
Governor / President / Deputy Director / Director / Associate Director for Policy / Major / Desk Officer / Assistant Commissioner for Policy / Executive Office / Assistant / Acting Director / Center for Scientific Review / /
Product
ZELNORM / approved drug / /
ProvinceOrState
Maryland / /
PublishedMedium
Public Law / the Center for Scientific Review / /
Technology
study protocol / information technology / http / /
[removed]Federal Register / Vol. 69, No[removed]Monday, March 15, [removed]Notices application for ZELNORM (U.S. Patent No. 5,510,353) from Novartis