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Rockville, Maryland, US
Healthcare Innovation Catalysts reposted this
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
❄️ 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
Healthcare Innovation Catalysts reposted this
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
Healthcare Innovation Catalysts reposted this
Happy 90th birthday, Peter Hutt! Thanks for the Food and Drug Law Institute (FDLI) and Christine Simmon for a great party. Fun catching up with many friends and colleagues, including Jeffrey Francer and David Korn!
Vice President, Head of Global Regulatory Policy and Strategy at Eli Lilly and Company
What a pleasure to wish the legendary Peter Hutt a happy 90th birthday at the Food and Drug Law Institute (FDLI) holiday reception and to catch up with former colleagues David Korn and Deb Autor. As many people know, Peter literally “wrote the book” on FDA law — as well as the original regulations in 21 CFR!
🌟 Great start to the FDLI Enforcement Conference today! HIC's Deb Autor shared insights on FDA's use of enforcement discretion as the panel explored very interesting cases! #FDLI #FDA #HIC #Innovation #Drugs #Devices #Compliance #EnforcementDiscretion
We're #hiring a Program Support Specialist. Apply for this remote position today or share this post with your network.
This is a fantastic opportunity for clinical investigators, health care professionals, and others involved in clinical research! FDA CDER Small Business and Industry Assistance (SBIA)
📣Now OPEN!! SBIA’s Annual FDA Clinical Investigator Training Course (CITC) - December 10 -12, 2024. Register early!! ➡️https://lnkd.in/eX7b83PY
Healthcare Innovation Catalysts reposted this
Coming on Wednesday! I hope you'll join us for this interactive session exploring when to interact, how to prepare, and how to optimize your FDA engagement for long-term success! Please join me and my esteemed former FDA colleagues, Phil Desjardins and Steve Silverman, as we share insights gained during our time with the agency. WHAT: Know Your Regulator- How to Effectively Engage FDA WHEN: Wednesday, October 23, 2024, 2:00-3:00PM ET WHO: Former FDA Panelists Deb Autor | CEO of Healthcare Innovation Catalysts Philip R. Desjardins | Partner at Arnold & Porter Steve Silverman | President at The Silverman Group
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!
Knowing how to effectively engage with your regulator is critical to long term success when operating in a regulated industry. On Wednesday, October 23, HIC CEO Deb Autor and her former FDA colleagues Philip Desjardins and Steve Silverman will discuss how they manage this delicate process with their clients. We hope you can join this interesting discussion! Register here ➡️ https://bit.ly/4eASEwX
Join us Wednesday, October 23, for an interactive webinar featuring former FDA leaders Philip Desjardins, Steve Silverman, and Deb Autor. This roundtable discussion—moderated by Bobby McMillin—will provide insights on effective FDA engagement, such as when it is appropriate to engage, finding the right engagement point, and the benefits of effective engagement. These insights will help participants move from unpredictable (and sometimes difficult) FDA exchanges to productive, long-term interaction. A live Q&A session will follow the panel. Register here ➡️ https://bit.ly/4eASEwX #FDA #Regulatory