The FDA (Food and Drug Administration) Drug Approval Process Training Course: Procedures for Submission of INDs, NDAs, ANDAs and 505(b)(2) (ONLINE EVENT: June 11-12, 2025)
The 'The FDA (Food and Drug Administration) Drug Approval Process Training Course' training has been added to ResearchAndMarkets.com's offering.
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.
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:
Certifications:
Key Topics Covered:
Day 1
Pharmaceutical Medicine and Documents
FDA History and Organisation
Legal Basis (Patent Exclusivity PDUFA, GDUFA, BsUFA)
Legal Basis Continued
Application and Submissions Types
Refusal to File
Investigational New Drug (IND) Applications
Getting Products to the Market Faster
FDA Meetings and Documentation
CTD Content - Setting the Scene
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
US Amendment Procedures
High Level Comparison US vs EU
Case Study
For more information about this training visit https://www.researchandmarkets.com/r/jjhwpo
About ResearchAndMarkets.com
ResearchAndMarkets.com is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends.
View source version on businesswire.com:https://www.businesswire.com/news/home/20250520108035/en/
CONTACT: ResearchAndMarkets.com
Laura Wood, Senior Press Manager
[email protected]
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KEYWORD:
INDUSTRY KEYWORD: FDA PHARMACEUTICAL HEALTH
SOURCE: Research and Markets
Copyright Business Wire 2025.
PUB: 05/20/2025 08:25 AM/DISC: 05/20/2025 08:24 AM
http://www.businesswire.com/news/home/20250520108035/en
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