Regulations are a necessary safeguard of the modern age—one that helps protect the safety of consumers. In the US, pharmaceutical drugs have been regulated for more than 100 years, dating back to the first federal controls enacted in 1848. As pharmaceutical companies continue to employ innovative science methods, the ability to understand and accurately interpret applicable regulations and guidance is critical to both successfully managing a product’s lifecycle and protect public health.
This course provides an overview of the history of pharmaceuticals in the US, 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.
Learning Objectives
Upon completion of this course, participants should be able to:
- Describe the function and responsibilities of FDA
- Identify and explain applicable regulations and technical requirements for investigational new drug (IND) applications 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
- 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, including periodic safety update reports (PSURs), 15-day reports, recalls, field alerts and Annual Reports
Target Audience
This course is intended for new regulatory and quality assurance professionals, as well as related departments interested in understanding the basics of US pharmaceutical regulations.