TypeOnline Course
Student Enrolled1
Price$180 / Rs. 12500
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Admission Process

Admission Process

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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

Certification: Certificate will be provided at the end of the course after completion of the final examination.

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 
Section 2Generic Drug - Strategic Understanding
Lecture 11Concept of Authorized Generics
Lecture 12Concept Building on LOE Strategies
Lecture 13Strategic Discussion on Evergreening - To Keep Generic Away
Lecture 14Advance Understanding on Para IV Filing
Lecture 15Para IV Notices - Handling and Managing
Lecture 16LOE Strategies for Innovator Brands with case study
Section 3ANDA Application Filing
Lecture 17Introduction and Overview of ANDA Submission Format
Lecture 18ANDA Application Format
Lecture 19Detailed understanding of DMF
Lecture 20Pratical Understanding on DMF preparation and filing
Lecture 21Understanding on GDUFA, DMF Fees and ANDA Approval
Lecture 22Approval Pathway - 505(b)(2)
Lecture 23Prior Approval Submission (PAS)
Lecture 24ANDA Fees
Lecture 25505(b)(2) VS. Suitability Petition : Case Based Learning
Lecture 26NCE Vs. 505b2 application - Case Based Learning 
Lecture 27FTF - 180 Days Exclusivity - Case Based Learning
Lecture 28Classic case study of the 505b2 filing
Lecture 29Strategic Planning in Combating 30 months stay strategies of innovator company- Case Based Learning
Lecture 30Practical Queries on different USFDA application and Filing 
Section 4Data Integrity and related Quality issues
Lecture 31Advance Training on Data Integrity
Lecture 32Establishment Inspection Report | 483 Observations | USFDA Warning Letter | Handling of FDA inspection | Closing of Warning Letter 
Section 5Final Examination