FDA Expectations for 505(b)(2) Regulatory Pathway for New Drugs

The FDA can approve small molecule drugs and some biologics through the 505(b)(2) regulatory pathway. This pathway allows an applicant to submit a new drug application using data from an already-approved product. Basically, this permits the applicant to rely on the safety and effectiveness of data from a previous product.

More specifically, a product seeking approval under 505(b)(2) must prove that investigations relied upon by the applicant were not conducted by or for the applicant. This can be difficult as many investigations are conducted by or for the applicant. Once the ten-year phase-in period is complete for biologics, a product approved under 505(b)(2) will also be approved under 351(k) according to the Affordable Care Act (ACA).

This webinar is designed to help industry better understand the FDA's regulatory pathway for 505(b)(2) so that certain drugs or biologics can be approved using this pathway more easily. The speaker will walk you through the FDA's current recommended practices.

Areas Covered in the Session :

• Applicable Regulations
• Definitions
• Common Misconception
• Categories Approvable under 505(b)(2)
• 505(b)(2) Requirements
• 505(b)(2) Applications: Contents
• CMC Requirements under 505(b)(2)
• Drug Examples Approved under 505(b)(2)
• Injectable Biologics Approved under 505(b)(2)
• Important Considerations
• Recommendations and Best Practices

Who Should Attend:

• Quality Assurance Departments
• Regulatory Affairs Departments
• Compliance Departments
• Clinical Affairs Departments
• Research and Development Departments
• Consultants
• All upper and mid-management professionals
• Everyone Interested in the FDA Drug Review and Approval Processes

Course Director: Kelly Thomas

Ms. Thomas has over two decades of cGMP hands-on industry experience in both pharmaceutical and medical device manufacturing operations. Her experience covers all Quality Systems; as well as, all areas of validation; including, process/product validation, facilities validation, CSV and 21 CFR Part 11, test method validation, equipment/automated processes and cleaning validation. Utilizing strategic thinking, risk based approaches, and Lean principles, she has demonstrated success in steering and managing complex projects within the pharmaceutical and medical device industries.