Drugs

CDER Small Business and Industry Assistance (CDER SBIA) Webinar on “Overview of FDA’s Proprietary Name Review Process” - July 15, 2014

The Food and Drug Administration, Center for Drug Evaluation and Research Small Business and Industry Assistance (CDER SBIA) is pleased to inform you of a unique opportunity for small business entities to learn more about the FDA and basic drug regulation. Our webinar series highlights various aspects of drug regulation.

These focused webinars support the CDER SBIA’s mission of promoting productive interaction with regulated industry by assisting small pharmaceutical business and industry with information relating to the development and regulation of human drug products.

On Tuesday July 15, 2014, CDER Small Business and Industry Assistance (CDER SBIA) hosted a webinar entitled Overview of FDA’s Proprietary Name Review Process.”

FDA published a notice in the Federal Register announcing the availability of the draft Guidance for Industry - Best Practices in Developing Proprietary Names for Drugs.

This webinar provided an overview of the Proprietary Name Review guidance that focuses on the safety aspects in the development and selection of proposed proprietary names for all prescription and nonprescription drug products and biological products. The draft guidance provides a qualitative systematic framework for evaluating proprietary names before submitting them for FDA review. FDA is issuing this guidance to help sponsors of drug and biological products develop proprietary names that are not potentially misleading and do not cause or contribute to medication errors. This webinar went over the guidance that represents FDA’s current thinking on this topic.

Speakers:
Lubna Merchant, M.S., PharmD
Associate Director
Division of Medication Error Prevention and Analysis
Office of Medication Error Prevention and Risk Management
Office of Surveillance and Epidemiology
Center for Drug Evaluation and Research
Food and Drug Administration

Kellie Taylor, PharmD, MPH
Director (acting)/ Division of Medication Error Prevention and Analysis
Deputy Director/ Office of Medication Error Prevention and Risk Management
Office of Surveillance and Epidemiology
Center for Drug Evaluation and Research
Food and Drug Administration


Lubna Merchant M.S, PharmD
Dr. Merchant currently serves as the Associate Director for the Division of Medication Error Prevention and Analysis (DMEPA). Dr. Merchant has worked in DMEPA since 2010. In her capacity as the Associate Director for DMEPA, she serves as expert/scientific advisor on medication errors associated with drug and biological products within the Office of Surveillance and Epidemiology, and other offices within the Center and outside agencies.

Kellie Taylor PharmD, MPH
Dr. Taylor currently serves as the Deputy Director of the Office of Medication Error Prevention and Analysis in the Office of Surveillance and Epidemiology in FDA’s Center for Drug Evaluation and Research’s (CDER) where she is responsible for the Center’s programs in risk management and medication error prevention.

Dr. Taylor is also currently serving as Acting Director for the Division of Medication Error Prevention and Analysis (DMEPA). In her capacity as the acting Division Director for DMEPA, she provides oversight, coordination, and technical expertise for the pre- and post-marketing activities involving medication error prevention and analysis of regulated drug and drug/device products, including the review of proposed proprietary names for CDER.

Closed captioning is provided.

For questions concerning the webinar, please contact CDER SBIA at:
(866)-405-5367 | (301)-796-6707

CDER SBIA webinar series: SBIA Workshops and Webinars

 

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