Tag Archives: FDA

05Sep/19
Can Digital Evidence Replace Clinical Evidence-Small (1)

Can Digital Evidence Replace Clinical Evidence?

A Straight from the Source Webinar Available On-Demand

FDA is encouraging the use of “Digital Evidence” to inform clinical trial design, predict clinical outcomes, support demonstration of safety and effectiveness, identify relevant patient populations, and support regulatory submissions. 

Digital evidence from in silico clinical trials have been shown to produce similar results as human clinical trials and under certain circumstances may replace clinical evidence. 

Join FDA’s Tina M. Morrison and Axendia’s Daniel R. Matlis for a live webinar on 18 SEP 2019 at 11:00 AM ET. 

We will discuss FDA’s perspective on: 

  • Shifting from traditional evidence sources to digital evidence  
  • How to create virtual patients with digital evidence to replace clinical evidence  
  • Examples of digital evidence in Pharma and Medical Devices used at FDA to initiate and augment clinical studies 
  • Creating an in silico clinical trial playbook
  • Why data in PDF’s are not sufficient 

Meet Your Trusted Sources

Tina and Dan for CC

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26Jun/19
Digital Evidence Webinar

FDA Discusses the Use of Digital Evidence to Accelerate Innovation

A Straight from the Source Webinar Available On-Demand

FDA is encouraging the use of “Digital Evidence to accelerate product innovation supporting rapid introduction of life-saving technology for patients “Digital evidence” is already being used at FDA to predict clinical outcomes, inform clinical trial design, support demonstration of safety and effectiveness, identify relevant patient populations, and support regulatory submissions. 

Join FDA’s Tina M. Morrison and Axendia’s Daniel R. Matlis for a live webinar on July 10 at 11:00 AM ET. 

We will discuss FDA’s perspective on: 

  • Shifting from traditional evidence sources to digital and real world evidence  
  • Modeling and Simulation to support improved quality and patient outcomes 
  • Examples of Digital Evidence currently in use at FDA 
  • The Review of the Futureharnessing the power digital and real world evidence through digital transformation 

Meet Your Trusted Sources

Tina and Dan for CC

Over 200 FDA employees are part of the Agency’s Modeling and Simulation working group. Find out what they are working on and more.  

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28May/19
Dan and Cisco 2019 Webinar

FDA Answers Your Questions on the New Approach to CSV

Q&A from an Axendia Straight from the Source (SftS) Webinar

By: Francisco Vicenty, FDA, CDRH and Daniel R. Matlis, Axendia, President

In our recent webinar, we discussed FDA’s perspective on Computer Software Assurance (CSA).  FDA has recognized that existing perceptions and approaches to computer system validation (CSV) are a significant barrier to improving digital capability, product quality, and patient safety and is working swiftly to reverse this trend.

In this “Straight from the Source” webinar, we discussed FDA’s perspective on CSA including:

  • FDA’s upcoming Guidance on CSA for Manufacturing, Operations, and Quality System Software
  • Applying critical thinking and risk-based principles to support technology modernization
  • Identifying Acceptable Records of Assurance
  • Leveraging CSA to accelerate digital transformation

There were many more questions submitted than could be answered in the time allotted.

Register and receive your internal-use copy of the full Q&A.

 

 

22Apr/19
Modern-Pharma-Mfg-Small-400by360

FDA is Enabling Innovation and Modernization

By: Thomas O’Connor, Sr. Chemical Engineer, US FDA

FDA is committed to supporting and enabling pharmaceutical innovation and modernization as part of the Agency’s mission to protect and promote public health. FDA recognizes that continuous manufacturing is an emerging technology that can enable pharmaceutical modernization and deliver potential benefits to both industry and patients. Continuous manufacturing can improve pharmaceutical manufacturing by, for example, using an integrated process with fewer steps and shorter processing times; requiring a smaller equipment footprint; supporting an enhanced development approach (e.g., quality by design (QbD) and use of process analytical technology (PAT) and models); enabling real-time product quality monitoring; and providing flexible operation to allow scale-up, scale-down, and scale-out to accommodate changing supply demands. Continue reading

22Mar/19
modernizing pharma manuf image

FDA Shares Quality Considerations for Continuous Manufacturing

A Straight from the Source Webinar Available On-Demand

 FDA is committed to supporting and enabling pharmaceutical innovation and modernization. The Agency recognizes that continuous manufacturing is an emerging technology that can enable pharmaceutical modernization and deliver potential benefits to both industry and patients.

Join FDA’s Thomas O’Connor, Ph.D. and Axendia’s Daniel R. Matlis for a live webinar.

Original Webinar Date and Time:  April 17th at 11:00 AM ET. 

We will discuss FDA’s perspective on pharmaceutical innovation and modernization including:

  • FDA’s draft guidance on Quality Considerations for Continuous Manufacturing
  • How continuous manufacturing can improve pharmaceutical manufacturing
  • Support of enhanced development approaches such as quality by design (QbD), process analytical technology (PAT) and models
  • Insights from dialogue with sponsors through the Emerging Technology Program, externally funded and internal research
  • Experiences from review and approval of five drug applications utilizing continuous manufacturing to date

Meet Your Trusted Sources

dan and thomas SFTS image

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