DIA: Driving Insights to Action
Science:Life Sciences
In 2002, the FDA established the Office of Combination Products (OCP) to help manage complicated jurisdictional issues in the regulatory review and approval of drug delivery devices and diagnostics growing in both number and complexity. “I can only imagine what the possibilities will be with respect to the use of things like artificial intelligence and smart devices as they pertain to the delivery of medical products going forward. I feel it’s going to go far beyond where we could have ever foreseen,” suggests Kim Quaintance-Lunn, Vice President and Head of US Regulatory Policy for Bayer, and a member of the program committee for DIA's Combination Products 2017 Conference, in this Global Forum podcast. “The challenge that comes with that is, of course, from a regulatory perspective, how do you regulate that? How do you get in front of an area that moves so quickly as to be hard to even predict?”
Califf: Digitization Will Return Humanity to Medicine
New Sources Changing the Meaning of Evidence?
AI Research Can Optimize Clinical/Operational Effectiveness
Has Joining ICH Accelerated Innovation in China?
Pricing Pitfalls in Prescription Drug Advertising
MID-NET Among PMDA’s First Steps Into RWE
Regulatory Science 2019: Leading or Holding Back Innovation?
23andMe: Information Empowering Patient Action
The Patient’s Most Engaging Question: Why?
EUnetHTA: Post-Launch Critical for Comparative Data
HSA Harmonizing Culture and Science in Singapore
Promoting Patient-Centric Business: MedComm in Latin America
Separate but Equal: Regulatory & Pricing Assessments in EU
Genetics Leading Modern Revolution in Cancer Care
Automation No Substitute for Scientific Leadership
R2D2 & C-17 New Landmarks in Canada’s Collaborative Pathways
Advanced Therapies Moving Upon Combination Platforms
Challenges in Generic Drug Safety & Surveillance
Interview with a DIA 2018 Patient Scholar
Novel Approaches to PV Collaboration
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