Healthcare Innovation Catalysts

FDA issued a notification about fraudulent data from some 3rd-party testing facilities. Generating high-quality evidence to support the safety and effectiveness of medical products is the core of FDA regulation. Developers and manufacturers of all sizes often must outsource testing. Q: How does a developer ensure that their contractors are performing high-quality testing and providing reliable reports? A: By having a good Quality Management System that includes strong vendor qualification criteria and audits.

FDA Alumni Association showing our support for FDA employees today at the White Oak Campus. #FDAProud !! #FDAAA

Please join us on Wednesday to learn more about FDA to industry transitions!

HIC expresses our heartfelt support to our friends at FDA who are enduring layoffs and difficult times. For our colleagues in industry, we want you to know that we're here to help you through these uncertain times. Having the right expertise is more critical than ever. With 65+ seasoned advisors and 450+ years of combined FDA experience, HIC provides expert guidance on clinical trials, submissions, GMP/QMS and GCP compliance, and FDA strategy to help you navigate ambiguity and accelerate approvals with confidence. #FDA #RegulatoryAffairs #HealthcareInnovation #Compliance #MedicalDevices #DrugDevelopment

This is what I'm talking about when I say that real-world evidence can be every bit as good, and even better than traditional stand-alone clinical trials. I'm proud, excited, and honored to be working with Alex Deyle and the entire Flatiron Health team to realize the vision that we had at FDA/CDRH when we issued the first real-world evidence guidance document. This is truly the way of the future. #RWD #RWE #RealWorldEvidence #PragmaticTrial

ICH E6(R3) – A New Chapter in Clinical Research Excellence The recent release of the ICH E6(R3) Guideline for Good Clinical Practice is a noteworthy step forward in modernizing clinical research. With the FDA poised to adopt this global standard, the updates focus on improving ethical, scientific, and operational aspects of clinical trials. Key highlights include: ? Quality by Design (QbD): A proactive approach to embedding quality into trial design, ensuring critical-to-quality factors are identified and addressed. ?? Risk-Based Approach: Tailoring trial design and monitoring to the risks involved, prioritizing participant safety and data integrity. ?? Technological Integration: Embracing digital health tools such as wearables and remote data capture, fostering efficiency and innovation. ?? Inclusivity and Diversity: Ensuring trials are representative of diverse populations to enhance the applicability of findings. ?? Enhanced Data Governance: Establishing robust data lifecycle management practices to maintain integrity, security, and compliance. ?? Expanded Annexes: Detailed guidance on trial operations, including investigator responsibilities, IRB/IEC roles, and adapting to emerging technologies. ICH E6(R3) makes progress by offering a flexible, globally harmonized framework to meet modern challenges while prioritizing ethical integrity and scientific excellence. ?Whether this guidance is flexible and adaptable enough to keep up with the artificial intelligence transformation in clinical research remains to be seen. Contact Healthcare Innovation Catalysts for guidance on the use of AI in clinical research. https://lnkd.in/eNeK4Mna #ClinicalResearch #ICHE6R3 #ArtificialIntelligence #GoodClinicalPractice #InnovationInHealthcare #HealthcareInnovationCatalysts

Join us as we say farewell to the second person to ever serve as FDA Commissioner twice, Dr. Robert M. Califf. Thank you, Dr. Califf, for your leadership in promoting and protecting public health!

Happy holidays from Healthcare Innovation Catalysts. We greatly appreciate the opportunity to work with such amazing clients, colleagues, and partners!

?? Season's greetings from Healthcare Innovation Catalysts! We have seen amazing growth in 2024, and look forward to another prosperous year to come. Happy Holidays from Deb Autor and Michael Singer! ?? #innovation #FDA #regulatory #devices #drugs #clinicaltrials #newyear #2024wrapup

Close to 200 people turned out for our annual FDA Alumni Association holiday party! What does it mean that Robert Califf, Commissioner of FDA, took home the Titleist golf balls with the FDAAA logo, but left behind the crystal statuette? ?? Good priorities! #FDA #FDAAA