How To Apply QbD to Drug Device Combination Products
Today, we invite Dr. Manfred Maeder of Novartis to share how Quality-by-Design is applied in the development of medical devices and drug device combination products. Previously, Dr. Lana Shiu of FDA shared the ongoing regulatory changes in drug device combination products. I recommend you listen to her presentation as...
QbD Implementation on Medical Devices (Drug Eluting Stents)
Does Quality by Design apply to Medical Devices? We’ve seen it coming down to combination products. Now QbD implementation on Medical Devices. My colleagues working in the medical devices claims Design Controls is comparable to QbD. Design controls is a FDA guidance to product development activities. However, it is...
FDA on Prefilled Syringes and Combination Products — What This Means for You
This regulation affects all of us. Most of us focus only on one of these: Drugs, Therapies, or Devices. However unexpected failures and mistakes happen more often at the interface of the three, shares Dr. Lana Shiu of CDRH at FDA. I met Dr. Lana Shiu after her presentation at...
QbD for Pre-filled Syringes and Injection Devices
This week, I’m at the 2014 PDA Universe of Prefilled Syringes and Injection Devices and 2014 PDA Drug Delivery Combination Products Workshop. Only two talks have “QbD” in their titles. The good news is that QbD jargons and practices are beginning to show up in other sessions. Earlier...
FDA Regulations on Mobile Medical Apps
Are you aware of the FDA Regulations on Mobile Medical Apps? FDA recently issued the Mobile Medical Applications (MMA) Guidance for Industry and Food and Drug Administration staff on Sept 25, 2013. The document outlines the agency’s regulation of mobile medical apps as devices and their intent to focus only...