Pharmaceuticals: US Regulations

This course covers the requirements to obtain prescription and over-the-counter drug approvals and other requirements that are in place to ensure compliance with FDA regulations.

Whether you are new to US pharmaceutical regulations or have been working in this field for some time, having the right tools and abilities to overcome challenges and meet professional expectations can be a never ending struggle. Get an in-depth understanding of pharmaceuticals in the US, beginning with historical justifications for why some pharmaceutical regulations exist today, and then take the plunge into an all-inclusive exploration of the current state of US pharmaceuticals. As pharmaceutical companies continue to apply innovative scientific methods, the ability to understand and accurately interpret applicable regulations and guidance is critical to both successfully managing a product’s lifecycle and to protecting public health.

This course covers the requirements to obtain prescription (Rx) and over-the-counter (OTC) drug approvals and other requirements that are in place to ensure compliance with US Food and Drug Administration (FDA) regulations, such as pharmacovigilance reporting, labeling updates and proper product promotion.

At a Glance

Target Audience: This course is intended for new regulatory and quality assurance professionals, as well as those already working in related areas or departments who are interested in understanding the basics of US pharmaceutical regulations.

Learning Level: Basic

Total Length of Course: 5 Hours

Pharmaceutical Certificate Elective

RAC Points: 5

Enrollment Period: 12 months

Learning Objectives

Describe the organization and responsibilities of FDA, with particular focus on the Center for Drug Evaluation and Research (CDER) Identify and explain applicable regulations and technical requirements for Investigational New Drug (IND) applications, key interactions during the drug development phase and New Drug Applications (NDAs)

Highlight the major differences between Rx and OTC drugs

Define the regulatory pathway of an OTC product in the US, including Rx -to -OTC “switched” products

Discuss advertising, promotion and labeling for pharmaceutical drugs, including different types of labeling, material submission requirements and possible enforcement actions resulting from violations

Explain the significance and relevance of various pharmacovigilance reports that may be required following the approval of a drug, including Periodic Adverse Drug Experience Reports (PADERs), Periodic Safety Update Reports (PSURs), 15-day Alert Reports, recalls, field alerts and NDA Annual Reports

Lesson Titles

Lesson 1: History of Pharmaceuticals

Lesson 2: Prescription Drug Submissions

Lesson 3: Over-the-Counter (OTC) Drugs

Lesson 4: Drug Advertising, Labeling and Promotion

Lesson 5: Postapproval Activities

This course is also included in: