Overview
The U.S. Food and Drug Administration’s (US FDA) India Office and the Drug Information Association’s (DIA) India Office will host a 2-day workshop on regulatory policies and best practices related to generic drug applications (aka., abbreviated new drug application [ANDA]) and the life-cycle management of approved applications.
This joint program offers a unique opportunity to hear from FDA subject matter experts on current regulatory perspectives on various generic drug application topics. FDA regulators will speak on topics such as the application review process, common deficiency trends including data integrity, pre-approval inspections, and post approval changes. This worskhop offers practical advice, case studies, and a deep dive into the ANDA review process. The workshop will provide an opportunity for participants to engage with the FDA subject matter experts for ANDA.
Program Committee
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Sarah E McMullen Country Director, FDA India Office
Food and Drug Administration, India -
Gregory Smith Deputy Director, FDA India Office
Food and Drug Administration, India -
Dhruv Shah Senior Technical Advisor
Food and Drug Administration, India -
Jacquin L. Jones, MSN, RN International Relations Specialist, FDA India Office
Food and Drug Administration, India -
Phuc Nguyen International Relations Specialist, FDA India Office
Food and Drug Administration, India -
Sudheendra Kulkarni Senior Technical Advisor,
FDA, India
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