1. FDA-CVM Activities Regarding Antimicrobial Resistance and Food-producing Animals Bridging the Gap Between Animal Health and Human Health November 13, 2013 Craig A. Lewis,…
1. A New Approach to Outsourced Drug Development: How Sponsor-CRO Clinical Delivery Alliances Improve Performance Therapeutic Foresight. Trusted Results. ™ 2. Page 2A New…
Slide 1 REMS Update NORD Corporate Council Meeting May 14, 2013 Theresa Toigo, RPh, MBA Associate Director for Drug Safety Operations Center for Drug Evaluation and Research,…
Slide 1 + Drug Development and Review Process Slide 2 + Objectives Learn the processes involved in drug discovery and development Define the phases involved in FDA drug approval…
Antimicrobial Resistance in Streptococcus pneumoniae Implications for Prescription Drug Labeling John H. Powers, MD Lead Medical Officer Antimicrobial Drug Development and…
(NEW DRUG APPLICATION) R.MEENAKSHI M Pharm (Pharm. Chemistry) R.MEENAKSHI M.PHARM(Chemistry),2010 CONTENTS HISTORY INTRODUCTION APPLICATION FORM IND REVIEW PROCESS NDA REVIEW…