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