Tag Pharmacovigilance

60 documents
Pharmacovigilance for Panama

Pharmacovigilance for Panama

UR47 UPPSALA REPORTS October 2009 For everyone concerned with the issues of pharmacovigilance Introducing our new Director PaniFlow UMC Signal work Commonwealth…
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SUMMARY REVIEW OF REGULATORY ACTION Date: From: August 21, 2009 Badrul A. Chowdhury, MD, PhD Director, Division of Pulmonary and Allergy Products, CDER, FDA…
How FDA Approves New Drugs and Evaluates Their Safety

How FDA Approves New Drugs and Evaluates Their Safety

How FDA Approves Drugs and Regulates Their Safety and Effectiveness Susan Thaul Specialist in Drug Safety and Effectiveness June 25, 2012 Congressional Research…
19910 Zidovudine Clinical Prea

19910 Zidovudine Clinical Prea

MOR NDA 19-910/S-035/Retrovir dosing 4 - 6 weeks 1 Medical Officer Review of Supplemental Labeling Revisions Prior Approval Recommendations for Pediatric…
Sop a123 Ae Sth Studies

Sop a123 Ae Sth Studies

CONTROLLED DOCUMENT- DO NOT COPY Research Department STANDARD OPERATING PROCEDURE STH Researcher Recording, Management & Reporting of Adverse Events for STH…
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