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

The United States Food and Drug Administration (FDA) can approve small molecule drugs and some biologics under the regulatory pathway 505(b)2.

The 505(b)2 regulatory pathway allows an applicant to submit a new drug application for approval of different formulations, dosage forms, indications or combination products of drugs and biologics that have been already approved by the FDA.

Basically, 505(b)2 permits an applicant to rely on the safety and effectiveness data of a previously-approved product.

More specifically, an application under the 505(b)2 is one for which one or more of the investigations relied upon by the applicant for approval were not conducted by or for the applicant and for which the applicant has not obtained a right of reference or use from the person by or for whom the investigations were conducted according to the applicable law.

For biologics, the 505(b)2 pathway offers a narrow category of biologics for marketing approval. It should be noted for biologics that any product approved under the 505(b)(2) pathway will be considered approved under the 351(k) pathway once the ten-year phase-in period is complete according to the Affordable Care Act (ACA).

This webinar is intended to help industry better understand FDA’s regulatory pathway 505(b)2 so that the 505(b)2 pathway can be better used for FDA approval of certain drugs or biologics.

The speaker will walk you through the FDA’s current recommended practices.

Areas Covered in the Session :

  • Applicable Statute(s) and 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
  • PASS-IT Recommendations: Best Practices
Who Should Attend:

  • CEOs
  • VPs
  • Compliance Officers
  • Attorneys
  • Regulatory Affairs
  • Clinical Affairs
  • Quality Assurance
  • R&D
  • Consultants
  • Contractors/Subcontractors
  • Anyone Interested in the FDA Drug Review and Approval Processes


Dr. David Lim

Dr. David Lim, Ph.D., RAC, ASQ-CQA. Dr. Lim is President and Principal of Regulatory Doctor (www.RegulatoryDoctor.us). As a leading industry speaker, Dr. Lim frequently presents global regulatory and quality compliance topics in various forums and meetings. Recently, Dr. Lim developed 510(k) templates ready for use compliant with e-Copy and RTA policy. In addition, Dr. Lim developed FDA inspection checklists for drug and medical device manufacturers based on his analysis of FDA inspectional observations cited in 483s for the past eight years. Dr. Lim provides his feedback to regulatory agency (e.g., US FDA) through public comments and also served as a panel member during the FDA’s transparency public meeting in 2009.

Dr. Lim contributes to the Regulatory Affairs Professional Society (RAPS) as an author and speaker. Dr. Lim leads and directs all research projects including pharmacovigilance, medical device reporting, recalls and patient safety signals being conducted at the Regulatory Doctor. Dr. Lim currently serves as a member of the Advisory Board for Inspection Insider published by FDA News.

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  • Login Information with Password to join the session, 24 hours prior to the webinar
  • Presentation Handout in .pdf format
  • Presentation from the Speaker
  • Feedback form
  • Certificate of Attendance
  • Recording access Information with Password to view the webinar, will be sent 24 hours after the completion of the Live webinar.
  • Presentation Handout in .pdf format
  • Certificate of Attendance