The USFDA India and DIA Workshop on Generic Drug Applications

The workshops will shed light on the resources available to facilitate the generic drug application process.

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USFDA United State Food and Drugs Administration
USFDA

Last Updated on December 24, 2023 by The Health Master

Generic Drug

The US Food and Drug Administration (USFDA) and the Drug Information Association (DIA) are set to conduct a series of workshops on Generic Drug in India, specifically:

In Ahmedabad from December 11 to 12, 2023,

In Hyderabad from December 14 to 15, 2023.

This joint effort aims to shed light on regulatory policies and best practices concerning generic drug applications, specifically abbreviated new drug applications (ANDA), and the life-cycle management of approved applications.

Workshop Details

The workshops present a unique opportunity for participants to gain insights directly from USFDA subject matter experts.

This collaborative program will cover a range of topics essential to the generic drug application process.

Objective of the Workshop

The primary goal is to share the expectations and insights of the USFDA regarding generic drug life cycle management.

The workshops are crafted to encourage active dialogue, providing a platform for a deeper understanding of regulatory expectations related to generic drug applications.

Workshop Agenda

The agenda includes sessions on the application review process, common deficiency trends, pre-approval inspections, and post-approval changes.

These workshops promise practical advice, case studies, and an in-depth exploration of the ANDA review process.

Speakers

The workshops will be led by a panel of esteemed experts from the USFDA’s India Office.

The lineup includes:

  • Sarah McMullen,
  • Gregory Smith,
  • Dhruv Shah,
  • Jacquin Jones,
  • Phuc (Phil) Nguyen,
  • Sudheendra Kulkarni,
  • Sarah Ibrahim,
  • Peter Capella,
  • Sharmista Chatterjee,
  • Aditi Thakur,
  • Utpal Munshi.

Application Review Process

One of the key areas of discussion will be the generic drug application review process.

Participants will gain valuable insights into the intricacies involved, ensuring a comprehensive understanding of the regulatory landscape.

Common Deficiency Trends

The workshops will address common deficiency trends, with a specific focus on issues such as data integrity.

Understanding these trends is crucial for applicants to enhance the quality of their submissions.

Pre-Approval Inspections

Pre-approval inspections play a pivotal role in the generic drug application process.

The workshops will delve into the details of these inspections, providing participants with a clearer picture of what to expect.

Post Approval Changes

After a generic drug is approved, there may be changes that impact its use.

The workshops will cover post-approval changes, ensuring participants are well-versed in managing modifications effectively.

Best Practices in Submission

The ANDA workshop will emphasize best practices in submitting and managing generic drug applications.

Participants will receive practical guidance on optimizing their submission processes.

Challenges in Application Review

Addressing challenges in the application review process is essential for improving overall efficiency.

The workshops will tackle common hurdles faced by applicants during the review phase.

Regulatory Support Mechanisms

Understanding the support mechanisms provided by regulatory bodies is crucial for applicants.

The workshops will shed light on the resources available to facilitate the generic drug application process.

Real-World Examples

Real-world examples experienced by USFDA regulators will be shared, offering practical insights into how regulatory expectations are navigated in actual scenarios.

Interaction Opportunities

The workshops will provide ample opportunities for participants to engage in questions and answers with USFDA subject matter experts.

This interactive format ensures a dynamic learning experience.

Expected Outcomes

The ultimate aim of the workshops is to increase compliance with USFDA regulatory expectations in future submissions.

Participants can expect to gain valuable knowledge and insights that will positively impact their approach to generic drug applications.

Disclaimer: This article contains information derived from the source mentioned below. Our team utilized an AI language model to rewrite and present the news or article in a unique format.

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