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
Course Syllabus:
- Fundamentals of the Abbreviated New Drug Application (ANDA)
- Submission expectations and content under GDUFA
- Chemistry, manufacturing and controls
- Bioequivalence
- 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
Section 1Fundamental Understanding in Generic Drugs
Lecture 1Introduction to drug discovery
Lecture 2Concept of Generic Drugs
Lecture 3Detailed Understanding on ANDA
Lecture 4Generic Drug User Fees Act (GDUFA)
Lecture 5Handling of orange book
Lecture 6Differentiation of 505(j) ANDA, 505(b)(2) NDA, 505(b)(1) NDA
Lecture 7First to File Generics
Lecture 8Complete Response Letter | Key understanding | Management and Action Plan
Lecture 9Advance Learning on 505B2 Pathway
Lecture 10Chemistry, Manufacturing & Controls
Lecture 11Patent & Exclusivity - Strategic Understanding | Patent Restoration| Orphan Drug Exclusivity (ODE) | NCE & NCI Exclusivity | GAIN Exclusivity | Pediatric Exclusivity | 180 days exclusivity
Section 2Generic Drug - Strategic Understanding
Lecture 12Concept of Authorized Generics
Lecture 13Concept Building on LOE Strategies
Lecture 14Strategic Discussion on Evergreening - To Keep Generic Away
Lecture 15Advance Understanding on Para IV Filing
Lecture 16Para IV Notices - Handling and Managing
Lecture 17LOE Strategies for Innovator Brands with case study
Lecture 18FDA Forms and How to fill the resources
Lecture 19Strategic Discussion: PreIND, EOP1, EOP2 - What to expect !
Section 3ANDA Application Filing
Lecture 20Introduction and Overview of ANDA Submission Format
Lecture 21ANDA Application Format
Lecture 22Detailed understanding of DMF
Lecture 23Pratical Understanding on DMF preparation and filing
Lecture 24Understanding on GDUFA, DMF Fees and ANDA Approval
Lecture 25Approval Pathway - 505(b)(2)
Lecture 26Prior Approval Submission (PAS)
Lecture 27ANDA Fees
Lecture 28505(b)(2) VS. Suitability Petition : Case Based Learning
Lecture 29NCE Vs. 505b2 application - Case Based Learning
Lecture 30FTF - 180 Days Exclusivity - Case Based Learning
Lecture 31Classic case study of the 505b2 filing
Lecture 32Strategic Planning in Combating 30 months stay strategies of innovator company- Case Based Learning
Lecture 33Practical Queries on different USFDA application and Filing
Section 4Data Integrity and related Quality issues
Lecture 34Advance Training on Data Integrity
Lecture 35Establishment Inspection Report | 483 Observations | USFDA Warning Letter | Handling of FDA inspection | Closing of Warning Letter
Section 5Final Examination
