Citeline Podcasts

Manufacturers that implement a so-called "system of quality model" will be best suited to assess traditional quality management systems in preparation for even more digital devices flooding the market, an Eli Lilly global quality leader says in this "Silver Sheet" visual podcast.

Speaking to The Gray Sheet at the Food and Drug Law Institute's annual meeting, FDA's Bakul Patel cautioned against trying to cram too much into mHealth legislations and said the agency alongside FCC is still mulling how to proceed with standardizing wireless test beds. Read the associated article here: https://www.pharmamedtechbi.com/publications/the-gray-sheet/41/17/podcast-patel-cautions-against-unintended-consequences-of-mhealth-legislation.

Cathy Burgess with law firm Alston & Bird spoke on a panel at the Food and Drug Law Institute annual conference about data integrity. In a post-panel chat with “The Gray Sheet,” Burgess says device firms are vulnerable to the same data-integrity issues that drug firms have been called out for in recent FDA enforcement actions. She says more FDA guidance would be useful for both industries.

Cathy Burgess with law firm Alston & Bird spoke on a panel at the Food and Drug Law Institute annual conference about data integrity. In a post-panel chat with “The Gray Sheet,” Burgess says device firms are vulnerable to the same data-integrity issues that drug firms have been called out for in recent FDA enforcement actions. She says more FDA guidance would be useful for both industries.

Cathy Burgess with law firm Alston & Bird spoke on a panel at the Food and Drug Law Institute annual conference about data integrity. In a post-panel chat with “The Gray Sheet,” Burgess says device firms are vulnerable to the same data-integrity issues that drug firms have been called out for in recent FDA enforcement actions. She says more FDA guidance would be useful for both industries.

King & Spalding's Quynh Hoang offers device manufacturers a handful of de novo tips – including urging firms to determine whether clinical studies are needed in relation to a potential de novo product – in this "Gray Sheet" podcast.

King & Spalding's Quynh Hoang offers device manufacturers a handful of de novo tips – including urging firms to determine whether clinical studies are needed in relation to a potential de novo product – in this "Gray Sheet" podcast.

King & Spalding's Quynh Hoang offers device manufacturers a handful of de novo tips – including urging firms to determine whether clinical studies are needed in relation to a potential de novo product – in this "Gray Sheet" podcast.

In the wake of troubling patient infections and deaths due to improperly sterilized duodenoscopes, human factors experts Michael Wiklund and Jonathan Kendler of UL-Wiklund Research & Design provide tips on writing effective instructions for use in this "Silver Sheet" podcast. Go here: http://youtu.be/S2yHi6OS9Fc to view the video presentation.

In the wake of troubling patient infections and deaths due to improperly sterilized duodenoscopes, human factors experts Michael Wiklund and Jonathan Kendler of UL-Wiklund Research & Design provide tips on writing effective instructions for use in this "Silver Sheet" podcast. Go here: http://youtu.be/S2yHi6OS9Fc to view the video presentation.