Regulatory Norms are ever-changing. There have been significant changes in FDA expectations of Abbreviated New Drug Applications (ANDAs) since the passage of the Generic Drug User Fee Act (GDUFA) in 2012. In this course participants will learn about FDA regulations and expectations for the content, submission, and review of ANDAs and the importance of regulatory strategy in the age of GDUFA. The ANDA format and technical submission requirements, FDA expectations, fees, timelines under GDUFA, and the nuances of ANDA strategy for the regulatory professional including patent certification, and exclusivity periods will be discussed. The course will also focus on suitability petitions and the 505 (b)(2) NDA as a strategy option.
Core Area of Learning: Focused Area of learning: ANDA, Generic Drug Launching Strategies, Para IV, 180 Days Exclusivity Handling, Drug Master File, GDUFA, Suitability petitions, 505B(2), FDA meeting handling detailed understanding.
Duration: Access for 7 days
Course Code: KPE-C-052
Who should attend this course?
- Those who are in strategic management or handling regulatory affairs of the generic drugs
- Experienced staff from related disciplines, e.g. manufacturing, marketing and sales
- Support staff
- Anyone requiring an overview of ANDA and generic drug approval
- Fundamentals of the Abbreviated New Drug Application (ANDA)
- Submission expectations and content under GDUFA
- Chemistry, manufacturing and controls
- Drug master files
- Introduction to GDUFA. Fees and FDA review timelines under GDUFA
- Overview of therapeutic ratings, patent certification, 180-day exclusivity
- What is a suitability petition and when to submit one
- When does a “generic-like” drug become a 505 (b)(2) NDA
Certification: Certificate will be provided at the end of the course after completion of the final examination.