Take a deeper dive

Webinar | Regulatory Pathways for Drugs, Devices, & Combination Products

This webinar covers regulatory pathways for drugs, devices, and combination products. Dr. Lamson provides his insights on the 505(b)(2) pathway for new drugs while Ms. Benokraitis discusses a variety of regulatory pathways for devices, including 510(k), Premarket Approval (PMA), and De Novo. The presentation concludes with a discussion of how these various regulatory pathways intersect for drug-device combination products.

At the end of this webinar, attendees should have a better understanding of:

  • How to use the 505(b)(2) pathway to streamline drug development effectively
  • Which device regulatory pathway is appropriate for your standalone device or combination product
  • The interplay of drug and device pathways for developing combination products

Meet the Presenters

Michael J. Lamson, Ph.D.
Vice President, Clinical Pharmacology & Pharmacokinetics | Nuventra

Dr. Lamson has over 28 years of experience in pharmacokinetics and clinical pharmacology. Dr. Lamson’s strategic regulatory experience includes product development for NDAs, sNDAs, ANDAs, and 505(b)(2) NDAs. His skills also include using innovative analytical methods, such as modeling and simulation, to evaluate PK disposition and in vivo drug delivery performance throughout drug development.

Kristin Benokraitis
Director of Quality & Operations | Gilero 

Ms. Benokraitis has over 17 years of experience working with medical and drug delivery devices. She began working at Gilero in 2007 as a Quality Engineer and became the Director of Quality and Operations in 2011. Kristin is the company’s regulatory subject matter expert, having authored multiple regulatory submissions. In addition, she has managed countless projects developing medical devices and combination products for a variety of clinical applications.

Explore Our Blog

Benefits of Utilizing the 505(b)(2) Pathway for Prodrugs

Over the past decade, at least 30 prodrugs have been approved by the US Food and Drug Administration (FDA). It…

Read More

Understanding CDISC SEND Data and How to Be Compliant

Nonclinical study data submitted to the FDA must align with the Clinical Data Interchange Standards Consortium (CDISC) Study Data Tabulation…

Read More

Pre-IND Meeting Guide: Benefits & How to Prepare

Regulatory guidelines allow for formal meetings between the FDA and sponsors or applicants to discuss the development and review of…

Read More