Mastering the FDA Drug Approval Process: Strategies for Success in the US Pharmaceutical Market (February 6-7, 2024)

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Dublin, Nov. 02, 2023 (GLOBE NEWSWIRE) — The “The FDA (Food and Drug Administration) Drug Approval Process Training Course” conference has been added to’s offering.

The US is the largest market globally for pharmaceutical sales, so having a good understanding of FDA procedures is vital for those submitting in this challenging region. This course will help clarify the US regulatory process, giving you a practical insight into FDA requirements and ensuring that you are fully up to date with all the latest developments.

The comprehensive programme will cover procedures for submission of INDs, NDAs, ANDAs and 505(b)(2), provide a useful insight into the organisation and structure of the FDA and its review processes, and highlight recent changes. The course will emphasise areas of interest to innovative manufacturers, but will also deal with issues relating to generic and over-the-counter drugs.

There will be ample opportunity for discussion with our expert trainer as well as other delegates and a practical workshop session to optimise learning.

Benefits of attending:

  • Review the latest FDA regulatory requirements for drug development
  • Understand FDA regulatory strategic needs
  • Ensure that you comply with FDA requirements for NDAs, ANDAs and 505(b)(2)
  • Discuss recent changes and developments with an industry expert and Improve your communication and interactions with the FDA

Who Should Attend:

This programme will be especially beneficial to those responsible for preparing US registration documents (INDs, NDAs, Biologics License Applications, etc), regulatory affairs personnel, lawyers and others responsible for advising companies on strategies for developing new drugs for the US market.


Day 1

Pharmaceutical Medicine and Documents

  • The role of regulatory affairs
  • The purpose of the Common Technical Document (CTD)

FDA History and Organisation

  • Review of FDA centers
  • Organization of the CDER and CBER
  • Differences between CDER and CBER

Legal Basis (Patent Exclusivity PDUFA, GDUFA, BsUFA)

  • 21st Century Cure Act
  • Patent and exclusivity
  • BsUFA

Legal Basis Continued

Application and Submission Types

  • Investigational New Drugs (IND)
  • New drug applications (NDA)
  • Abbreviated new drug applications (ANDA)
  • Over-the-counter drugs (OTC)
  • Biologics license applications (BLA)
  • Orphan drug designations

Refusal to File

  • Reasons for refusal
  • The regulatory process

Investigational New Drug (IND) Applications

  • Review of the content of an IND

Getting Products to the Market Faster

  • Review of expedited programs in the US
    • Fast Track designation
    • Breakthrough Therapy designation
    • Accelerated Approval
    • Priority Review designation

FDA Meetings and Documentation

  • FDA communication philosophy
  • Different meeting types
    • Scope
    • Format
    • Procedure

CTD Content – Setting the Scene

  • Lean authoring to ensure possible document re-use for multiple purposes
  • A review of the different modules

CTD Content – M1

Day 2

CTD Content – M3 and Corresponding M2

CTD Content – M4 and Corresponding M2

CTD Content – M5 and Corresponding M2

Submission Format and Methods

  • Study tagging files
  • Datasets
  • Case report forms
  • Bioresearch monitoring (BIMO) clinical data

US Amendment Procedures

  • A review of US amendment procedures (incl. annual reports, minor/major changes)

High-Level Comparison US vs. EU

  • A review of the main differences in terms of dossier content and procedures

Case Study

For more information about this conference visit

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