US FDA Drug Review and Approval Process

The U.S. FDA and Center for Drug Evaluation and Research (CDER) is in charge of overseeing the drug approval process before a drug is marketed. CDER is responsible for ensuring that both brand and generic drugs work correctly and that the health benefits outweigh the known risks. Both agencies review each drug using an independent team of clinicians and scientists who evaluate safety, efficacy and labeling of the drug product. After approval of the drug is complete, the FDA follow-up continues to make sure new drugs continue to be safe and effective. 

Why You Should Attend:

This webinar will discuss the 4 stages of the drug review and approval process. It will discuss what a New Drug Application is and how it gets submitted. Participants will understand who is on the FDA Advisory board and how it works. The webinar will also discuss the cost of getting a new drug to market and what happens after the final approval.

Participants should attend this webinar to learn the 4 phases of the drug approval process, the cost of getting a drug to market and what happens after the final drug approval.

Areas Covered in the Session :

• What is the FDA approval process?
• The 4 phases of the approval process
  • Pre-clinical NDA
  • Clinical
  • New Drug Application (NDA)
  • Post- marketing risk assessments
• What is an NDA
  • PDUFA - Prescription Drug User Fee Act
  • Orphan Drug Program
  • Accelerated Drug Approval 
  • Fast Track
  • Breakthrough Therapy
  • Priority Review
• Who is on the FDA Advisory Board?
• Cost of getting a drug to market
• What happens after final approval
• What is the Medwatch safety program

Who Should Attend:

• Quality Assurance Departments
• Research and Development Departments
• Regulatory Affairs Departments
• Compliance Officers
• Production Departments
• Engineering Departments
• Process Owners
• Document Control Specialists
• Quality Auditors
• Clinical Affairs Professionals
• Consultants
• Everyone Interested in the FDA Drug Review and Approval Processes

Course Director: Joy McElroy

Joy McElroy entered the pharmaceutical industry in 1992 shortly after earning a Bachelor of Science degree at North Carolina State University. She began at Pharmacia & UpJohn performing environmental monitoring and sterility testing. From there she moved into a supervisory role at Abbott Laboratories where she oversaw the quality control lab. In 1998, Ms. McElroy moved to Wyeth Lederle and worked in quality assurance, performing GMP compliance audits, batch record reviews, and holding annual GMP training for new employees. After working in quality assurance for a few years, she moved into equipment qualification and cleaning validation at Mallinckrodt. She has worked all around the United States performing GMP compliance audits, writing and executing cleaning validations, equipment qualifications, and performing technical writing. With over 30 years total experience in the pharmaceutical and biologics industries, Ms. McElroy has gained extensive knowledge of quality assurance, process and cleaning validation, environmental monitoring, equipment qualification, sterilization, GMP compliance auditing, and technical writing.  Joy currently works for Actalent Services, LLC as the Validation Manager for sciences where she works with a team of highly qualified technical individuals to provide managed services to pharmaceutical, medical device and biologics companies around the world.