ANDA Submission and GDUFA Final FDA Guidance

Event Information
Product Format
Prerecorded Event
60 minutes
Product Description

Bring Your Generic Drugs to Market Faster and in Compliance with the GDUFA II Requirements 

Just as everyone was beginning to get conversant with GDUFA's confusing three-tier system, the FDA, on July 4, 2018, finalized the GDUFA II guidance! The final guidance simplifies the designation of amendments into two broad categories—Standard or Priority—while classifying them as either Major or Minor. But that has not yet made things easier for many ANDA (Abbreviated New Drug Applications) applicants. There’s still a lot of ambiguity around amendments to ANDAs and PASs (Prior Approval Supplements) – and not having clarity could cost your organization time, money, and other resources.

Join regulatory expert Charles H. Paul in this highly instructive webinar on the FDA review goals for amendments under GDUFA II. Paul will walk you through the amendment format and submission process. You will learn how the GDUFA II review goals apply to amendments to ANDAs and PASs; how the amendment submissions may affect the review goal dates; how ANDA or PAS deficiencies may cause the FDA to request a major amendment, as well as how to request the FDA to reconsider classifying a major amendment.

This webinar will bring absolute clarity on the FDA review goals for amendments under GDUFA II. After attending this webinar, you will achieve a greater working understanding of GDUFA II and its most recent final guidance. Moreover, you’ll also get to know how the FDA will process amendments submitted before GDUFA II. Plus, you’ll be confident in your ability to bring generic drugs to market quickly and in compliance with the GDUFA II requirements. 

Session Highlights

  • Purpose and scope of GDUFA II
  • The FDA’s process for classifying major, minor, and unsolicited amendments to ANDAs or PASs
  • The amendment format and submission process
  • The FDA review goals for amendments under GDUFA II
  • How the FDA will process amendments submitted before GDUFA II
  • How ANDA or PAS deficiencies cause the FDA to request a major amendment or classify deficiency responses as a major amendment
  • How to request the FDA to reconsider classifying a major amendment
  • How high quality standards are maintained through inspections and risk-based approaches
  • The process of and reasons for requiring the identification of the facilities involved in the manufacture of generic drugs and the associated Active Pharmaceutical Ingredients (APIs)
  • How amendment submissions may affect review goal dates

Who Should Attend

  • Compliance and regulatory affairs professionals
  • Project managers
  • QA & QC managers
  • R&D staff
  • Generic drug manufacturers
  • API manufacturers
  • ANDA sponsors
  • Consultants
  • Directors, associate directors and associates
  • Generic drug industry professionals


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About Our Speaker

Charles H. Paul

Charles H. Paul is the President of C. H. Paul Consulting, Inc. – a regulatory, training, and technical documentation consulting firm. Charles is a management consultant, instructional designer and regulatory consultant and has led C. H. Paul Consulting, Inc. since its inception over 25 years ago. He regularly consults with Fortune 500 pharmaceutical, medical device, and biotechnology firms assisting them in achieving human resource, regulatory, and operational excellence....   More Info
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