Professional Training

US-FDA Drug Submission Procedures

PTI, Online
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Course description

US-FDA Drug Submission Procedures

The US is the largest market for pharmaceutical and biotech products making it a key strategic goal for organisations. In order to take advantage of the market opportunity, it is imperative to gain speedy regulatory approval for your products to support a successful launch of a new innovator or generic therapy. Like all regulatory approvals, the US FDA process is challenging for professionals to navigate as you need to understand all the latest procedures to ensure a positive outcome.

This LIVE Online Academy will provide you with a comprehensive understanding of the US regulatory processes such as Investigational New Drug Applications (IND) and New Drug Applications (NDA). In addition you will gain an insight into the workings of the FDA review process and learn best practice for requesting information from the FDA Regulators. On completion of the course, you will have a practical insight into the FDA’s requirements for new drug development and drug registration dossiers. You will also learn how to prepare a generic drug submission for fast approval, crucial in the competitive generic market.

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Suitability - Who should attend?

This course has been specificallydesigned to address the training needs ofexecutives who are or will be involved in thepreparation of development plans and/orregistration dossiers.

  • Compliance Managers
  • Documentation Managers
  • Product Registration Personnel
  • Project Managers in Regulatory Affairs
  • Marketing Managers
  • Clinical Research Personnel
  • Key contributors to the submission package for the US market

Training Course Content

  • Work your way through the laws and regulations governing the registration of prescription drugs in the US
  • Submit complete dossiers by understanding the critical elements of US INDs and NDAs
  • Meet the data requirements for INDs and NDAs
  • Communicate better with the FDA by knowing its structure and the interactions within the agency
  • Know how to obtain information from the FDA
  • Understand the logistics of sponsor-FDA interactions

Why choose PTI

On average, delegates of their online academies said: 

Quality of content:


85% had applied content during the course to their role

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