Drug development and regulation
1 CLIA Waiver Guidance Carol C. Benson 1 and Marina V. Kondratovich 2 1 Associate Director, Division of Chemistry and Toxicology Devices, OIVD, CDRH, FDA.
Office of Science and Technology Center for Devices and Radiological Health, FDA William A. Herman eHealth Technologies and the FDA.
ClinicalTrials.gov Why Does it Affect Me? Should I Be Concerned? Adapted from the work of the Clinical and Translational Science.
The Draft Guidance Word Version.doc
Dug development and regulation
Lecture one, units 1 2 pharm
Practicum of Health Science Class. The signature on a class-II written prescription A. may be stamped B. may be made by prescriber’s agent C. must be.
P HARMACY L AWS. 1906 Pure Food and Drug Act Enacted to stop sale of inaccurately labeled drugs All manufacturers required to put truthful info on labels.
Review of Federal Pharmacy Laws Joe Bruno Presentation to the Maine Pharmacy Association 3/21/2015.
Moving to Agile in an FDA Environment An Experience Report August 27, 2009.
FDA’s Policies, Procedures, and Systems: Effects on Provider and Information Technology Sectors
