A beautiful day on the FDA White Oak Campus!
What a great day tailgating at FDA representing the FDA Alumni Association. The message is out -- we always welcome current FDA employees as members! Thanks to Robert Califf, Michael Rogers, MS, Vijay Walia, and Steve Silverman for the picture!
Politics
Senator Rand Paul has introduced a resolution to repeal the FDA's LDT Final Rule. He has been a vocal opponent to VALID and the introducer of VITAL. Despite your politics, Senator Paul has been a defender of the interests of small labs and clinical lab innovation. I got to meet him in DC a few years ago. Check out the details of his new resolution here: https://lnkd.in/e5BTsZQb.
The Final FDA DCT Guidance is Here—and We’re Not Mad at It! 🤷♀️ In her latest blog, Catherine Gregor breaks down the most impactful changes from the FDA’s 2024 guidance on Decentralized Clinical Trials (DCTs). Two major updates include the removal of the HCP task log and clarified sponsor oversight—helping both sites and sponsors simplify their workflows. 👉 Read more on how these changes are set to streamline DCTs: https://hubs.li/Q02Tx7-j0
I'm speaking at CDISC interchange tomorrow in Berlin together with Katarina Hedman. If you are there, feel free to join our session where we will talk about: Efficient Construction of ADaM and Safety Output, Following the New FDA ST&F Guide
Rare Disease breakthroughs are important to everyone! Why’s that? The advances in treatment, or progression management, of rare diseases can provide trailblazing insights for more common ailments. This Virtual Public Meeting also an opportunity for organizations seeking to impact UN SDG3 - Health and Well-Being - because the United Nations Sustainable Development Goals and the 2030 Agenda seem to ensure that “no one is left behind.” No one being left behind requires that we address ALL diseases, no matter how small the patient population might be. The Chiaramello Lab and Mito-EpiGen Program Team will be joining this virtual meeting on Rare Diseases organized by FDA to conclude the Rare Disease Day. We encourage anyone interested in rare diseases, or more mainstream well-being issues, to join this opportunity to share ideas and learn from others. Our founder, Dr. Anne Chiaramello explains, “This is an invaluable opportunity for patients and providers to participate in discussions on clinical trials for rare diseases and on patient engagement at the FDA.” There will be a diverse range of speakers who will discuss topics including clinical research, FDA’s initiatives to advance rare disease medical product development and FDA’s patient engagement efforts. Free continuing education (CE) credit (4.25 hours) is available for eligible health care professionals, as well! In weeks following the Virtual Public Meeting, we will provide ideas about how any business can contribute to tackling rare diseases, to ensure that “no one is left behind.” #mitochondrialdisease #mitochondria #lhonplus #melas #rarediseaseday #rarediseaseday2024 #sdg3 #sdgs #2030agenda #clinicaltrials #innovationinhealth https://lnkd.in/gJcPtQMz
Join the FDA for a special #RareDiseaseDay 2024 virtual meeting on Friday, March 1, 2024 from 9AM - 4:30PM EST. Sign up in advance here: https://lnkd.in/eSdVGJy2
Strategic Quality Leader: Orchestrating Operational Excellence, Risk Mitigation, and Global Growth | Expert in GMP Compliance, Data Integrity and Business Integration
🚨🇺🇸Exciting changes at the #FDA! A complete #transformation and #reorganization are underway. Here are two key highlights showing how these shifts are benefiting US citizens. Did you know that about every 30 minutes an inspection is being initiated? Watch the video to learn more!🍀🚨
Recently, the FDA completed one of its largest transformations, impacting almost every part of the agency. This installment of FDA In Your Day highlights two of the many examples of the important work the FDA is doing every day to keep us safe!
Last Chance! Register today to talk with Adam, myself, and many others about sIRB and the upcoming FDA sIRB mandate. Explore the importance of a well-defined sIRB action plan in our upcoming webinar. Stay ahead of the curve and ensure your research operations are compliant and efficient. Reserve your seat today! #ComplianceWebinar #ResearchExcellence
Navigating the regulatory landscape? Our team is here to help. Check out the Bracken FDA Meeting Request Calculator which will help you plan and understand the necessities for your unique project. https://lnkd.in/eBCm_Ncq #FDAMeetings #RegulatoryAffairs #LifeSci #Bracken
Seeking FDA approval? The regulatory process is complex, but we've got you covered. Bracken's FDA Meeting Request Calculator serves as your ultimate tool for navigating the regulatory pathway with precision and confidence. Gain invaluable insights into the timing and steps necessary to secure that crucial FDA meeting, tailored to your project's unique timeline. Regulatory journeys can vary, but with the meeting calculator and its accompanying robust checklist, you'll be on the road to success. Try it today: https://lnkd.in/dTjaun62 #FDAMeetings #RegulatoryAffairs #LifeSci #Bracken
Seeking FDA approval? The regulatory process is complex, but we've got you covered. Bracken's FDA Meeting Request Calculator serves as your ultimate tool for navigating the regulatory pathway with precision and confidence. Gain invaluable insights into the timing and steps necessary to secure that crucial FDA meeting, tailored to your project's unique timeline. Regulatory journeys can vary, but with the meeting calculator and its accompanying robust checklist, you'll be on the road to success. Try it today: https://lnkd.in/eqFh7_-T #FDAMeetings #RegulatoryAffairs #LifeSci #Bracken
Seeking to help biotechnology, pharmaceutical and medical device companies advance their life-impacting ideas.
Seeking FDA approval? The regulatory process is complex, but we've got you covered. Bracken's FDA Meeting Request Calculator serves as your ultimate tool for navigating the regulatory pathway with precision and confidence. Gain invaluable insights into the timing and steps necessary to secure that crucial FDA meeting, tailored to your project's unique timeline. Regulatory journeys can vary, but with the meeting calculator and its accompanying robust checklist, you'll be on the road to success. Try it today: https://lnkd.in/gtVmjWWX #FDAMeetings #RegulatoryAffairs #LifeSci #Bracken
Seeking FDA approval? The regulatory process is complex, but we've got you covered. Bracken's FDA Meeting Request Calculator serves as your ultimate tool for navigating the regulatory pathway with precision and confidence. Gain invaluable insights into the timing and steps necessary to secure that crucial FDA meeting, tailored to your project's unique timeline. Regulatory journeys can vary, but with the meeting calculator and its accompanying robust checklist, you'll be on the road to success. Try it today: https://lnkd.in/gkNduWF3 #FDAMeetings #RegulatoryAffairs #LifeSci #Bracken
