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Abbvie FDA Response

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Page 1: Interim Response From FDA CDER to AbbVie, Inc

CDER Office of Compliance - Food and Drug Administration · PDF fileCDER Office of Compliance ... FDA compliance focal point for imports & exports of CDER regulated drugs ... • List

US FDA Perspectives on Biosimilar Biological Products · Steven Kozlowski, M.D. Director, Office of Biotechnology Products. OPS/CDER / U.S. FDA. 2014 Biotechnology Technology Summit

CDER New Drugs Program 2017 Update - Food … New Drugs Program: 2017 Update Patrick Frey Chief of Staff Office of New Drugs, CDER/FDA FDA/CMS Summit December 5 th, 2017 2 Housekeeping

 · FDA – CDER – RedI: Focus on CGMP & FDA Inspections – Participant List These participants granted permission to share their contact information Eileen Zhou Research Associate

Design and Statistical Analysis of Thorough QT (TQT) Studies Yi Tsong, Ph.D., CDER/FDA Co-author – Joanne Zhang, Ph.D., CDER/FDA The opinions presented

Improving FDA/Industry Interactions: Suggestions from FDA/CDER Statisticians

1 Efficacy Results NDA 22092 (MTP-PE) Laura Lu Statistical Reviewer Office of Biostatistics FDA/CDER

Novo Nordisk's Victoza FDA CDER Proprietary Name Review

Trial Design Issues in SLE Joel Schiffenbauer FDA/CDER DAAODP

FDA CDER RedI: Focus on CGMP & FDA Inspections Participant ... · PDF fileFDA – CDER – RedI: Focus on CGMP & FDA Inspections – Participant List These participants granted permission

CDER Computational Science Center - c-path.org · Chuck Cooper, M.D. Computational Science Center Office of Translational Sciences CDER, FDA Computational Science Center: Leveraging

Good Review Practices and QMS Implementation: an FDA ... · and QMS Implementation: an FDA Perspective David J. Cummings Office of Pharmaceutical Science (OPS) CDER/US FDA 2012 APEC

cGMP in the USA Training by CDER FDA

FDA/CDER SEND PilotFDA/CDER SEND Pilot - CDISC · FDA/CDER SEND PilotFDA/CDER SEND Pilot Lauren Murphree Mihalcik, Ph.D. Co-chair, IT Subcommittee, PTCC OND CDER FDAOND, CDER, FDA

2016 CDISC Japan Interchange Program CDISC Japan Interchange Program.pdfFDA-CDER Presentation Dr. Stephen Wilson, Director, Division of Biometrics III, FDA-CDER FDA-CDER Presentation

Recent FDA 3Rs Efforts- CDER, CVM, CDRH, CTP, …...Recent FDA 3Rs Efforts- CDER, CVM, CDRH, CTP, and NCTR Abby Jacobs, PhD, ATS on behalf of USFDA May 2017 1 ICH and Human Pharmaceuticals

The Quality System (QS) Train is Moving Fast at FDA Lana L. Pauls, MPH Director, Quality Management Staff CDER/FDA

Vinod P. Shah, Ph.D. Chair, Topical Drug Products WG OPS/CDER/FDA

Eileen Navarro MD, FACP Medical Officer, OCS, OTS, CDER, FDA · 2018-05-08 · OCS, OTS, CDER, FDA. 2 WHAT MEDICAL REVIEWERS CAN DO WITH STANDARDIZED DATA AND METADATA RECEIVED IN

Dr Dev Kambhampati | FDA CDER Novel New Drugs Approved, 2013

Steve Wilson, DrPH (Biostatistics) Deputy Director, Division of Biometrics II, CDER, FDA

General Principles: FDA IntroductionLisa M. LaVange, PhD Director, Office of Biostatistics Oceiff of Transalonalti Sciences ,CDER ,FDA November 27, 2012 General Principles: FDA IntroductionIssues

2018 Results Conference Call - Polyphor...1 FDA CDER Pharmacology Review: application number 22-311, FDA CDER Clinical Pharmacology Review: application number 22-311, mean of studies

1 ODAC September 13 th, 2005 Tarceva ® (erlotinib) Adrian Senderowicz, M.D. DDODP, CDER FDA

Chenxiong (Charles) Le, Ph.D. OBI/OB/OPaSS/CDER, FDA Cardiovascular and Renal Drugs

Quality by Design Approaches to Analytical Methods -- FDA ... fda/published... · 1 Quality by Design Approaches to Analytical Methods -- FDA Perspective Yubing Tang, Ph.D. FDA/CDER/ONDQA

Regulatory Perspectives on the Thorough QT/QTc Study 2005 FDA/Industry Workshop Washington DC September 16, 2005 Juan (Joanne) Zhang, Ph.D. CDER/FDA *Acknowledgement:

PART I: CDER TASK ORDER TABLE OF CONTENTS: …/media/Supporting... · TABLE OF CONTENTS: CDER RECORDS MANAGEMENT TASK ORDER ... approximately 3,500 FDA staff supporting the records

Update from FDA CDER - FDA Law Blog...Aug 03, 2019  · Update from FDA CDER Theresa Mullin, PhD ... •Develop standards to more consistently gauge state of quality maturity observed

FDA - Roadmap for Engaging with CDER Public … - Roadmap for Engaging with CDER Public Workshop May 12, 2017 A Matter of Record (301) ... 9 NDA at the FDA 10 Milena Lolic, MD,

Global Medical Cures™ | Novel New Drugs- 2013 Summary CDER FDA

Drug Release Specification: In Vivo Relevance Ajaz S. Hussain, Ph.D. Deputy Director, OPS/CDER/FDA

FDA perspectives: Biosimilar Development with a Lens on Quality - … · 2015. 11. 19. · Steven Kozlowski, M.D. Director, Office of Biotechnology Products OPS/CDER / U.S. FDA FDA/PQRI

Derivation and Validation of Parenteral Classification ......Apr 04, 2018  · • TTC applied by FDA CFSAN in evaluation of food packaging migrants, flavoring agents • FDA/CDER

Ram C. Tiwari Associate Director Office of Biostatistics, CDER, FDA [email protected]