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.

Learn more on what you can expect from the DIA-US FDA-ANDA WORKSHOP: Present And Future Perspectives On Generic Drug Life Cycle Management, meet the program committee and explore the covered topics – download the brochure by filling the form.

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.

We look forward to your participation!