Insight at Biologics

Helping you navigate through the maze of drug and device development.

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Episodes

Tuesday May 21, 2024

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.

Tuesday Apr 16, 2024

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.

Tuesday Nov 14, 2023

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

Tuesday Jul 18, 2023

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

Tuesday Jun 20, 2023

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

Tuesday May 16, 2023

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.

Tuesday Apr 18, 2023

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.

Tuesday Mar 21, 2023

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

Tuesday Feb 21, 2023

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

Tuesday Jan 31, 2023

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

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