FDA Approval Process for Combination Products

The United States Food and Drug Administration (FDA) reviews, clears or approves regulatory applications for drugs, biologics, medical devices including in vitro diagnostic devices (IVDs) and combination products.

It is imperative that firms identify and map evolving regulatory requirements so that regulatory submissions for in particular, combination products, can be better prepared for and managed with awareness in advance.

This seminar is intended to discuss regulatory requirements relevant and applicable to combination products. It is further intended to discuss CGMP requirements for combination products.

The best practices for enforcing a practical, actionable and sustainable regulatory approaches will be discussed, helping to save a significant amount of resources (time, efforts and financial).

In this seminar, the speaker will discuss what firms should consider and address when developing combination products and navigating through FDA’s regulatory pathways.

Areas Covered in the Session :

  • Applicable Laws and Regulations
  • FDA Guidance
  • Definitions
  • Regulatory Requirements for Combination Products
  • Implementing Compliance to Quality System Regulations
  • Implementing Compliance to Drug cGMP Requirements
  • Implementing Compliance to With Biological Product and HCT/P Requirements
  • Comparative Discussion on 21 CFR Parts 210/211, 600-680, 820, and 1271
  • Common Misconceptions
  • Adequate Implementation of Regulatory Requirements
  • Recent FDA Approvals of Combination Products
  • Best Practices: Dos and Don’ts
  • Speaker’s PASS-IT Recommendations


Who Will Benefit:

  • CEOs
  • VPs
  • Compliance Officers
  • Attorneys
  • Regulatory Affairs
  • Clinical Affairs
  • Quality Assurance
  • R&D
  • Consultants
  • Contractors/Subcontractors
  • Personnel looking for a general understanding of the FDA Combination Product Process

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