• Activity INFORMATION

  Overview

  Before a drug can be approved for marketing in the U.S. by the FDA, it must undergo testing to ensure that it is safe and efficacious. The approval is a slow and costly process, typically taking 8-12 years or more. However, seriously ill patients may not have the luxury of waiting for definitive regulatory approval, and disease activists have been advocating for faster availability of potentially life-saving therapies for decades. The FDA has responded with programs that speed up the approval process, create temporary approval, and expand access to treatments undergoing clinical trials. The recent pandemic has resulted in a resurfacing of questions and controversy regarding the speed and safety of investigational product approval and access. This lesson is designed to help pharmacists deal with these issues overall.
  

  Handouts

  • Homestudy PDF :   21010H03.pdf Download

  Financial Support By

  PharmCon

• Learning OBJECTIVES

  Pharmacist

  Describe the drug approval process.

  Characterize and identify the legal and regulatory features of the FDA’s expanded access programs.

  Distinguish between compassionate use, emergency use authorization, and accelerated approval and how they apply to recent events.

  Pharmacy Technician

  Describe the drug approval process.

  Distinguish between compassionate use, emergency use authorization, and accelerated approval and how they apply to recent events.

  Characterize and identify the legal and regulatory features of the FDA’s expanded access programs.

  Nurse

  Describe the drug approval process.

  Distinguish between compassionate use, emergency use authorization, and accelerated approval and how they apply to recent events.

  Characterize and identify the legal and regulatory features of the FDA’s expanded access programs.

• Activity ACCREDITATION

  Activity Type

  Knowledge

  CE Broker

  20-766355

  Universal Activity Number

  Pharmacist 0798-0000-21-010-H03-P
  Pharmacy Technician 0798-0000-21-010-H03-T
  Nurse 0798-0000-21-010-H03-N
  

  PharmCon is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.

  PharmCon is an approved course provider for continuing education for nurses by the Florida Board of Nursing. PharmCon is also recognized by the California Board of Nursing as a provider of nursing programs.

  In order to obtain a Statement of Credit, participants must score no less than a 70% on the activity's test and complete a program evaluation.

• Activity INSTRUCTION

  Faculty

  Gerald  Gianutsos, JD, PhD, BS Pharm, MS Associate Professor Emeritus, Department of Pharmaceutical Sciences, University of Connecticut School of Pharmacy

This continuing education activity is held as copyright by PharmCon, Inc. Through this notice, PharmCon, Inc. grants permission of its use for educational purposes only. These materials may not be used, in whole or in part, for any commercial purposes without prior permission in writing from the copyright owner(s).