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.


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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
recording single
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upto 10 attendees

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