Save the date for FDA's upcoming MSI Informational Day! Mark your calendar for September 18!
SAVE THE DATE: FDA's Minority Serving Institutions (MSIs) Informational Day set for Wednesday, September 18, 2024 from 9 am - 5 pm ET Registration will be opening soon.
WHAT'S NEXT FOR THE FDA IN 2025?📅 Join POLITICO's AgencyIQ on December 10 for an insightful webinar exploring how the FDA’s priorities might shift under the incoming Trump administration. Regulatory experts Alexander Gaffney, MS, RAC and Laura DiAngelo will share key insights on emerging trends, anticipated guidance, and the potential impact of political developments on the life sciences industry. Register now to secure your spot and prepare for 2025! 👇 https://lnkd.in/emgzHnV3 #AgencyIQ #FDA #LifeSciences #RegulatoryAffairs #Webinar
Knowing how to effectively engage with your regulator is critical to long term success when operating in a regulated industry. On Wednesday, October 23 my former FDA colleagues Steve Silverman, Deb Autor and I will discuss how we manage this delicate process with our clients. I 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
The FDA has two pathways for emergency research: the use of an investigational product in an individual following 21 CFR 50.23 (50.23 studies) and research on investigational products in broader emergency situations under 21 CFR 50.24 (50.24 studies). Emergency research is complex and regulatorily risky. Fortunately, WCG’s IRB experts delve into this topic in our latest blog post. Read about the special considerations when conducting research under 50.23 and 50.24 now at https://lnkd.in/eV8Uvztz #WCG #blog #FDA #FDAemergencyguidance
The only constant is change – especially in regulations. The FDA's proposed sIRB mandate signifies a dramatic shift in power from sites to sponsors, which is guaranteed to have a seismic impact on our industry. Advarra's James Riddle shares three important steps forward for sponsors & CROs in navigating this change. 👇 Full article by James here: https://lnkd.in/gUQTngKK #ClinicalResearch #ClinicalTrials
Everyone is talking about the new FDA Guidance on diversity in #clinicaltrials. Here, Denise N. Bronner, Ph.D., breaks down what's good AND bad about the new guidance. https://lnkd.in/gTcTpg9T #diversityinclinicaltrials #clinicaltrialdiversity
🔍 Curious about the new FDA LDT Final Rule? 🧪 Shannon Bennett, MS, MBA, breaks down the key terminology every clinical lab professional needs to know to stay ahead. From compliance requirements to industry impacts, this article will help you navigate the changes confidently. Read the full article here 👉 https://bit.ly/3TD0gqu #ClinicalLab #FDA #LDT #LaboratoryCompliance #LabProfessionals
ELIQUENT Life Sciences provides timely insights. Here's what new in Informed Consent.
ELIQUENT Experts, Liz Oestreich and Tom Berry, examine a new FDA guidance on the importance of obtaining informed consent. Read their analysis at https://lnkd.in/gGRfTpcs
GRS CMC-Strategy, Biologics at BMS| Biosimilars SME| passionate Regulatory Professional| Making positive impact on Healthcare by accelerate drug submissions ®ulatory approvals| People Leader|
Learn from Reviewers(FDA): very good and informative FDA webinar on : Regulatory Do’s and Don’ts: Tips from FDA https://lnkd.in/gq_QcyKM
We are looking forward to next week's webinar, Charting a Path to FDA Advisory Committee Success in a Sea of Change. Our panel, including Irene Laurora, PharmD, Senior Vice President, Scientific Affairs at Perrigo, Brian L. Strom, MD, MPH, Chancellor, Rutgers Biomedical and Health Sciences Rutgers, The State University of New Jersey, and Steven Weisman, PhD, Global President, Clinical and Regulatory, Lumanity, will discuss the anticipated changes the US Food and Drug Administration (FDA) is expected to make to the Advisory committee meetings (AdCom) process, the implications of these potential changes to their business and clinical development models, and the potential strategies that can be used to prepare for the coming changes to FDA Advisory Committees. Register to join the discussion and ask your questions at https://buff.ly/3IJb3JR #FDA #RegulatoryAffairs #AdCom #FDAAdComMeetings #Biotech #Pharma
I had a great conversation with Industry peers on the FDA user fee programs and the negotiation planning process. For those that were not able to make it to the RAPS Regulatory Intelligence program, the linked article did a great job of highlighting the issues we should be thinking about now. Thanks to my co-precentors and experts Alexander Gaffney, MS, RAC, Lucy Vereshchagina, PhD, Jeffrey Francer, and Stephen Mason of AuRIC Strategies. https://lnkd.in/ey27BKN6