DIA
Drug Information Association Logo

Introduction to US Institutions and Regulatory Authority (FDA)

| Online

« Back to Listing

Overview 

The course, a Thomson Reuters Cortellis Regulatory Online Learning module, describes the foundation and organization of US government institutions and regulatory authorities, federal rulemaking processes, and the legal basis for and evolution of US food and drug legislation. It explores in detail the roles and responsibilities of the Department of Health and Human Services (HHS) and Food and Drug Administration (FDA). The course concludes with an overview of the FDA review and approval process for new drug applications (NDAs) and biological license applications (BLAs).

Featured Topics 

  • US government institutions and regulatory authorities
  • US food and drug legislation
  • HHS
  • FDA

Who Should Attend 

Professionals and experts in the pharmaceutical, biotechnology, and medical device fields

Learning Objectives 

Participants who complete this course should be able to:

  • Describe the structure and functions of the US government
  • Outline the federal rulemaking process
  • Identify the milestones of US food and drug laws and regulations
  • Discuss the role and organisation of the Department of Health and Human Services
  • Explore the functions and structure of the Food and Drug Administration
  • Introduce the new drug application (NDA) and biologics license application (BLA) review process

The course takes an average of 1.5 hours to complete.

Contact Information 

Linda Belmont, DIA
Phone +1.215.293.5818
Linda.Belmont@diahome.org

Technical Requirements 

Click here for minimum system requirements.

Registration Fees 

Other Fees

Individual
$360.00
Register Online

Unless otherwise disclosed, the statements made by speakers represent their own opinions and not necessarily those of the organization they represent, or that of the Drug Information Association. Speakers, agenda and CE information are subject to change without notice. Recording of any DIA educational material in any type of media is prohibited without prior written consent from DIA.

« Back to Listing Back To Top