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Documents Regulation of Labeling and Promotion Edward P. Richards Harvey A. Peltier Professor of Law Louisiana...

Slide 1Regulation of Labeling and Promotion Edward P. Richards Harvey A. Peltier Professor of Law Louisiana State University School of Law [email protected] http://biotech.law.lsu.edu…

Documents Diane L. Heinz, DVM, MBA Director Policy and Regulations Staff Center for Veterinary Medicine...

Slide 1Diane L. Heinz, DVM, MBA Director Policy and Regulations Staff Center for Veterinary Medicine Foundations of Regulation Slide 2 The Federal Government is composed…

Health & Medicine 2011 raps presentation subcontractors software social media fox rev 2

1. Software, social media, and subcontracting Interactive case-based medical device session Tracey Fox (GE Healthcare) Erik Vollebregt (Axon Lawyers) 2. Agenda Approach Brief…

Documents recent updates in cosmetic technology

1. Recent Updates in Cosmetic Technology Dr. Khaled Al-Qaoud R&D manager Jordan Company For Antibody Production (MONOJO) 2. Personal Care • ((For the first time, the…

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1. Большие Данные в биомедицине Юрий Никольский, Директор по науке, Биомед кластер 2. DNA sequencing timeline…

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DMFs Under GDUFA: DMF Basics Small Business Webinar 2013 DRUG MASTER FILES UNDER GDUFA: DMF Basics Arthur B. Shaw, Ph.D. FDA DMF Expert FDA Small Business Office Webinar…

Documents Microbiology UCM092226

ORA Lab Manual, Volume IV, Section 2-Microbiology Page 1 of 79 This document is uncontrolled when printed: 2/22/2013 For the most current and official copy, check the Internet…

Documents Day1.3 - Lee - A Filing Reviewer's Perspective

Julia Lee, Pharm.D. Regulatory Support Branch Division of Labeling and Program Support (FDA│CDER│OGD) A Filing Reviewer’s Perspective on Electronically Submitted Documents…

Documents Information about Rx Drugs: Regulatory and Marketing Issues Ilisa B.G. Bernstein, Pharm.D., J.D....

Slide 1Information about Rx Drugs: Regulatory and Marketing Issues Ilisa B.G. Bernstein, Pharm.D., J.D. Director of Pharmacy Affairs U.S. Food and Drug Administration May…

Documents CBER Compliance Update FDLI Enforcement, Litigation and Compliance Conference December 8, 2014 Mary....

Slide 1 CBER Compliance Update FDLI Enforcement, Litigation and Compliance Conference December 8, 2014 Mary Malarkey, Director Office of Compliance and Biologics Quality…