Bringing novel cell and gene therapy products to market can be challenging for both nonclinical and CMC. David Pepperl, Diana Colleluori, and Robert Kutner return to talk with James C Taylor about it!
For smoother sailing with an IND, it can help to have a meeting with the FDA before the IND. But how do you do that and what do you need? Find out from Aleese Hopkins and Samira Shirwa.
When you have an anomalous lab result, you just might be in trouble. However, Chris Vessely can help you close the case of what went wrong, help you find a way to save the day, and help keep you from getting in trouble in the first place.
Security from cyberattack for medical devices is paramount. And the FDA wants you to have a plan for it. Becky Ditty and Donna-Bea Tillman tell you how to be prepared. Guidance documents: Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions: Guidance for Industry and Food and Drug Administration Staff. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/cybersecurity-medical-devices-quality-system-considerations-and-content-premarket-submissions Postmarket Management of Cybersecurity in Medical Devices: Guidance for Industry and Food and Drug Administration Staff. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/postmarket-management-cybersecurity-medical-devices Cybersecurity in Medical Devices: Refuse to Accept Policy for Cyber Devices and Related Systems Under Section 524B of the FD&C Act: Guidance for Industry and Food and Drug Administration Staff (related to the requirements per the Consolidated Appropriations Act, 2023) https://www.fda.gov/regulatory-information/search-fda-guidance-documents/cybersecurity-medical-devices-refuse-accept-policy-cyber-devices-and-related-systems-under-section Cybersecurity for Networked Medical Devices Containing Off-the-Shelf (OTS) Software https://www.fda.gov/regulatory-information/search-fda-guidance-documents/cybersecurity-networked-medical-devices-containing-shelf-ots-software Playbook for Threat Modeling devices https://www.mitre.org/publications/technical-papers/playbook-threat-modeling-medical-devices
Changes are coming to regulatory submissions publishing and we talk about two of them, eCTD 4.0 and standardized data, with Ben Wimmer.
How prepared is your facility? Being prepared is crucial and in this episode Vince Narbut takes you through commercial readiness.
The ICH has released a guidance which may allow you to forego animal carcinogenicity testing in favor of a weight of the evidence argument. We conclude our two-part discussion of why to do that and how to do that with Bruce Pearce.
The ICH has released a guidance which may allow you to forego animal carcinogenicity testing in favor of a weight of the evidence argument. We begin our two-part discussion of why to do that and how to do that with Bruce Pearce.
How can your organization continue to know what it's doing after people move on? Institutional memory. We talk about it with Kerin Ablashi.
How well does it work and how can you illustrate that? Diana Colleluori explains potency assays and best practices with them.
HeeSun Smaldore discusses the intricacies of deciding when to hire an outside consultant.
The regulatory agency doesn't get a lot of time with your IND submission. To figure out how to make the most of that time, we talk with Emily Noonan Place.
You may not have everything that you need when it comes to making a drug or device submission. How do you know? With a gap analysis. David Pepperl explains it in our conversation.
Using your own cells to help you heal isn't science fiction anymore. Robert Kutner takes us into the world of in vivo cell therapy.
Bringing a drug or device to market can be arduous. In this interview with Debra Barngrover of Biologics Consulting, we learn how a consultant can help bring your picture into focus. Guest: Debra Barngrover Host: James C. Taylor