News & Insights

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.

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

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

Pharmacology and toxicology expert, Bruce Pearce, continues sharing his insight about the new FDA S1B guidance R1 addendum. These changes may allow you to forgo carcinogenicity testing in favor of a weight of evidence argument. On this episode of Insight at Biologics, we explore the many factors involved, including the 2 year rat and rasH2 mouse studies, pharmacologic mechanisms, toxicology studies, and more.

The ICH has released a new guidance which may allow you to forgo animal carcinogenicity testing in favor of a weight of the evidence argument. We begin our two-part discussion of why this has been added, including the goals of the addendum, on this episode of Insight at Biologics featuring expert Bruce Pearce. And, tune in next time for part 2 to find out how to go about this.

In this episode of Insight at Biologics, industry expert Kerin Ablashi delves into institutional memory and knowledge management in the pharmaceutical industry. Discover exactly what institutional memory is, the role it plays in regulatory compliance, operations, and product development, as well as how you can develop knowledge management systems and continuity plans to support your organization, no matter what size.

In this episode of Insight at Biologics, industry expert, Diana Colleluori, explains everything that cell & gene therapy manufacturers need to know about potency assays. Learn about the definition, FDA guidances and regulations, best practices, and how to overcome the hurdles in potency assay development on this episode of Insight at Biologics.

On this episode of Insight at Biologics, HeeSun Smaldore, Business Unit Lead, shares some helpful thoughts about the intricacies of deciding when to hire an outside consultant.

On this episode of Insight at Biologics, Senior Consultant and industry expert Dr. Emily Noonan Place from Biologics Consulting chats with James Taylor about IND submissions and the review process. The fact is that the regulatory agency doesn't get a lot of time with your IND submission. How, then, does one optimize their IND submission to make the most of the allotted time in the review? And, how do you avoid the most common pitfalls? Find out all of this and more on this episode of Insight at Biologics.

Are you working on a drug or device submission? An FDA gap analysis can actually save you time and money by ensuring your regulatory compliance. David Pepperl explains the importance of performing a gap analysis and more in this episode of Insight at Biologics.