This webinar provides practical insights into how to navigate FDA expectations in NDA and ANDA submissions for combination products in the context of the current guidance.
Presented by Badre E. Hammond, MBA, Associate Director Business Development, Aptar Pharma and Wendy Bolf, Regulatory Affairs Manager, Aptar Pharma, this webinar looks to decode the FDAs recent combination drug product guidance as it applies to DPIs, pMDIs, and nasal sprays.
In April 2018, the FDA released guidance for quality consideration for pMDI and DPI affecting the inhalation approach to ANDA/NDA applications. This comes on the back of final FDA Guidance for Combination Products issued in January 2017, which defines a Combination Product as a product composed of two or more different types of medical products (i.e., a combination of a drug, device, and/or biological product with one another). There are three types of combinations products: single entity, co-packaged, and cross-labelled. The drug applicant therefore needs to demonstrate compliance with all cGMP regulations applicable to each of the constituent parts included in the Combination Product.
This webinar provides guidance on how the 2018 guidance affects future submissions and summarizes Combination Products FDA guidance focusing on respiratory and nasal drug products, specifically DPIs, pMDIs, and Nasal Sprays. It will also share insights on optimal approaches to help secure approval in this changing and challenging regulatory landscape.
VP Commercial Operations, Aptar CSP
Badre Hammond’s background is in Biochemistry with 14 years’ experience in pharmaceutical product development with focus on nasal and pulmonary drug delivery systems. Mr. Hammond has broad experience in managing development of novel drug product programs for the pharmaceutical market from formulation development, pre-clinical, CMC, to clinical phase.
Regulatory Affairs Manager
Wendy Bolf’s expertise is in Regulator Affairs with a BASc in Chemical Engineering and she has specialized in drug delivery systems for 20+ years. Mrs. Bolf has headed up the regulatory affairs department and has developed strategies for Aptar’s Drug Master Files and directly supported numerous FDA inspections on site as well as Type C meetings with FDA in order to gain approval of strategies including CMC sections, approval of INDs, NDAs, and ANDAs – mostly specializing in nasal and pulmonary drug delivery. Mrs. Bolf has been involved from the device regulatory side in supporting the approval of dozens of drug products (NDA and ANDAs) on the US market. In her current role, she is involved in Combination Product regulatory strategies for Aptar Pharma.