Citeline Podcasts

In this week's podcast, "Gray Sheet" journalists discuss a recent FDA gathering on patient-focused device labeling, legal updates, the recent advisory panel addressing safety concerns with an permanent birth control device, UDI updates and our plans for next week's AdvaMed conference.

In this week's podcast, "Gray Sheet" journalists discuss a recent FDA gathering on patient-focused device labeling, legal updates, the recent advisory panel addressing safety concerns with an permanent birth control device, UDI updates and our plans for next week's AdvaMed conference.

Voices From AdvaMed 2015: Avalere’s Lakshman Ramamurthy On Balancing Regulatory And Reimbursement

Summary: In the first of a series of podcasts planned in conjunction with the upcoming AdvaMed 2015 conference San Diego, we talk to Lakshman Ramamurthy, a VP with Avalere Health who will be moderating the conference’s Super Session on balancing regulatory and reimbursement factors when developing a medical device.

Voices From AdvaMed 2015: Avalere’s Lakshman Ramamurthy On Balancing Regulatory And Reimbursement

Summary: In the first of a series of podcasts planned in conjunction with the upcoming AdvaMed 2015 conference San Diego, we talk to Lakshman Ramamurthy, a VP with Avalere Health who will be moderating the conference’s Super Session on balancing regulatory and reimbursement factors when developing a medical device.

On this week's podcast, "Gray Sheet" reporters discuss the departure by Steve Ubl from AdvaMed to head PhRMA, FDA clinical trial review improvements, cybersecurity tips, a federal preemption update and a new diagnostics enforcement action by FDA.

On this week's podcast, "Gray Sheet" reporters discuss the departure by Steve Ubl from AdvaMed to head PhRMA, FDA clinical trial review improvements, cybersecurity tips, a federal preemption update and a new diagnostics enforcement action by FDA.

This week, Gray Sheet reporters talked about Robert Califf, who has been nominated by President Obama to be the next commissioner of FDA. We also touched on next-generation sequencing regulations and the latest on the Precision Medicine Initiative.

This week, Gray Sheet reporters talked about Robert Califf, who has been nominated by President Obama to be the next commissioner of FDA. We also touched on next-generation sequencing regulations and the latest on the Precision Medicine Initiative.

This week, Gray Sheet reporters talked about Robert Califf, who has been nominated by President Obama to be the next commissioner of FDA. We also touched on next-generation sequencing regulations and the latest on the Precision Medicine Initiative.

FDA's Zivana Tezak says she is pleasantly surprised at the high level of complexity that stakeholders brought to a recent meeting on using curated databases to support next generation sequencing (NGS). She says the conversations are a jumping point for the agency as it plans to hold back-to-back workshops on genomic testing in November.