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Agency Presentations

GlobalSubmit is pleased to provide you with access to recent agency presentations, since this is such an important means of keeping up to date with guidance and advice. We will continue to add presentations as they become available.

UPDATE on GDUFA and FDA's Office of Generic Drugs, February 20, 2014

 

GPhA Annual Meeting, Kathleen Uhl, MD, Acting Director, Office of Generic Drug CDER/FDA

Approved Drugs 2013: Report Issued January 2014

Novel New Drugs 2013 Summary, US FDA Center for Drug Evaluation and Research

 

CDER New Drug Review: 2013 Update, December 11, 2013

 

FDA/CMS Summit, John K. Jenkins, M.D., Director, Office of New Drugs Center for Drug Evaluation and Research

 

EDM and ERS/eCTD: Impact of e-Initiatives on Content and Context, December 5, 2013

DIA EDM Webinar eCTD Update, Mark Gray, Director, Division of Data Management Services & Solutions

 

CDER Small Business Webinar on Guidance for Industry, November 18, 2013

ANDA Submissions - Refuse-to-receive Standards, Johnny Young, Office of Generic Drugs (OGD)/CDER/FDA

 

 

GPhA/FDA ANDA Labeling Workshop/USP User Forum, September 11, 2013

 

Submitting High Quality eCTD Submissions to FDA/OGD, Constance Robinson, Regulatory Information Specialist, Division of Data Management Service and Solutions CDER

 

 

DIA 2012 Annual Meeting, Philadelphia, PA June 27, 2012

The State of Electronic Submissions at CDER, Virginia Hussong, Office of Business Informatics, OPI, CDER

eCTD Module 1 Update Part 1, Constance Robinson, Regulatory Information Specialist, eSubmission Support, Office of Business Informatics, OPI, CDER

eCTD Module 1 Update Part II, Mark Gray, Director, Division of Regulatory Review Support, Office of Business Informatics, CDER

Draft Module 1 Update, 1.15 Promotional Materials, Marci Kiester, Pharm D, Associate Director of Operations, OPDP, CDER

 

Pharmaceutical Regulatory Writing & Submissions Conference Baltimore, MD May 14-15, 2012

Overview of Current ICH Submission Standards and Their Impact on the Industry, Justin A. Molzon, Associate Director for International Programs, CDER, FDA

 

 

DIA Module 1 Townhall, February 9, 2012

eCTD M1 Update: General Overview of the Comments, Constance Robinson, Regulatory Information Specialist, eSubmission Support, Office of Business Process Support, CDER

Draft Module 1 Update (1.15 Promotional Materials), Marci Kiester, Pharm D, Associate Director of Operations, OPDP (formerly DDMAC), CDER

Key Modifications to Module 1, Jared Lantzy, Regulatory Information Specialist, Electronic Submission Support Team, Office of Business Informatics

 

 

DIA Electronic Submissions: The 10th Anniversary Conference San Diego, CA November 15-17, 2011

 

Electronic Submissions Update, Virginia Hussong, Office of Prescription Drug Promotion (OPDP), CDER

eCTD Module 1 Update, Constance Robinson, Regulatory Information Specialist, eSubmission Support, Office of Business Process Support, CDER