ANDA Submission and GDUFA Final FDA Guidance 2019 is a webinar that covers topics such as:
- The FDA’s process for classifying major, minor, and unsolicited amendments to ANDAs or PASs
- Purpose and scope of GDUFA II
- The FDA review goals for amendments under GDUFA II
- The amendment format and submission process
- How ANDA or PAS deficiencies cause the FDA to request a major amendment or classify deficiency responses as a major amendment
- How the FDA will process amendments submitted before GDUFA II
- How high quality standards are maintained through inspections and risk-based approaches
- How to request the FDA to reconsider classifying a major amendment
- How amendment submissions may affect review goal dates
- 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)
ANDA Submission and GDUFA Final FDA Guidance 2019 is intended for:
- Project managers
- Compliance and regulatory affairs professionals
- R&D staff
- QA & QC managers
- API manufacturers
- Generic drug manufacturers
- Consultants
- ANDA sponsors
- Generic drug industry professionals
- Directors, associate directors and associates
