Insight at Biologics

14. When to take an early FDA meeting, with Aleese Hopkins and Samira Shirwa

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.

13. Getting Out of Trouble, with Chris Vessely

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.

12. Cybersecurity for Medical Devices, With Becky Ditty and DonnaBea Tillman

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) Softwarehttps://www.fda.gov/regulatory-information/search-fda-guidance-documents/cybersecurity-networked-medical-devices-containing-shelf-ots-software
Playbook for Threat Modeling deviceshttps://www.mitre.org/publications/technical-papers/playbook-threat-modeling-medical-devices

11. eCTD 4.0 and standardized data, with Ben Wimmer

Changes are coming to regulatory submissions publishing and we talk about two of them, eCTD 4.0 and standardized data, with Ben Wimmer.

10. Commercial Readiness, with Vince Narbut

How prepared is your facility? Being prepared is crucial and in this episode Vince Narbut takes you through commercial readiness.

9. Weight of Evidence vs Carcinogenicity Testing Part 2, 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 conclude our two-part discussion of why to do that and how to do that with Bruce Pearce.

8. Weight of Evidence vs Carcinogenicity Testing Part 1, 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.

7. Institutional Memory, with Kerin Ablashi

How can your organization continue to know what it's doing after people move on? Institutional memory. We talk about it with Kerin Ablashi.

6. Potency Assays, with Diana Colleluori

How well does it work and how can you illustrate that? Diana Colleluori explains potency assays and best practices with them.

5. When you should hire a consultant, with HeeSun Smaldore

HeeSun Smaldore discusses the intricacies of deciding when to hire an outside consultant.