Citeline Regulatory

Accelerate your path from pipeline to patient: https://ow.ly/NrJV50TGhlz. NorstellaLinQ connects 74 billion data points, paving the way for breakthroughs in drug development and commercialization: https://ow.ly/NrJV50TGhlz. • Insights of 500,000 investigators • Tens of thousands of clinical trials across 185 countries • Hundreds of brand launches • Tens of thousands of forecasts Get closer to the patient than ever before. Learn more about NorstellaLinQ from Norstella, the parent company of Citeline: https://ow.ly/NrJV50TGhlz.

Get started with your free trial to Pink Sheet today: https://ow.ly/YY3n50Sx6Mn.

Nothing about accelerated approvals is ever simple, but sponsors should take some comfort in how the US FDA is codifying the general withdrawal procedures. Sue Sutter's story, part of a series analyzing the agency's recent guidance, is now outside the Pink Sheet paywall, courtesy of Citeline Regulatory. https://lnkd.in/e3gmEixY

Download 5 key articles from our expert journalists at Pink Sheet: https://ow.ly/8GuV50UnNQS. Every drug sponsor aims to leverage Artificial Intelligence, but understanding regulatory limits is crucial. With health authorities worldwide placing a sharper focus on AI applications that impact patient care, knowing where to draw the line can be challenging. This article bundle offers insights from Asia, Europe, and the U.S. on the emerging rules for AI in healthcare. _____ Follow Citeline Regulatory, giving you the information, tools and services needed to maintain clinical trial disclosure compliance, mitigate risk, and increase transparency.

Download 5 key articles from our expert journalists at Pink Sheet: https://ow.ly/LHTm50UnNNU. Every drug sponsor aims to leverage Artificial Intelligence, but understanding regulatory limits is crucial. With health authorities worldwide placing a sharper focus on AI applications that impact patient care, knowing where to draw the line can be challenging. This article bundle offers insights from Asia, Europe, and the U.S. on the emerging rules for AI in healthcare. _____ Follow Citeline Regulatory, giving you the information, tools and services needed to maintain clinical trial disclosure compliance, mitigate risk, and increase transparency.

PINK SHEET: US FDA Generic Drug Approvals, Other Actions Declined As Approval Times Climbed In FY 2024 •Who should read this? Generic drug developers and brand sponsors are worried about eventual generic competition. •What is it about? The US FDA is approving fewer products, and approving them more slowly, than in years past. •Why is it important? The industry and agency dynamics that led to this slowdown will have implications for the pending negotiations on the renewal of the user fee program. Citeline Citeline Commercial Citeline Regulatory #genericdrugs #FDA #drugapprovals https://lnkd.in/ecK42Mz8

A slowdown of generic drug approvals could create challenges for industry and the US FDA ahead of negotiations on the renewal of the user fee program. Derrick Gingery's story is now outside the Pink Sheet paywall, courtesy of Citeline Regulatory. https://lnkd.in/e7JebbR2

Stay ahead of evolving regulations with AI-driven compliance solutions: https://ow.ly/AIqY50UorQZ. Struggling to navigate the ever-changing world of clinical trial disclosure? Discover how AI can streamline your approach in our latest whitepaper as we explore how intelligence compliance tools can save you time, enhance accuracy and ensure you meet global transparency demands. _____ Follow Citeline Regulatory, giving you the information, tools and services needed to maintain clinical trial disclosure compliance, mitigate risk, and increase transparency.

Since 18 June 2024, CTIS transparency regulations have changed significantly. Are you in the know? https://ow.ly/lNtE50UnL7f Key changes for clinical trial disclosure: • Deferrals are no longer available in CTIS • Sponsors can protect commercially confidential information and personal data through a redaction in 'documents for publication' • Publication timelines vary based on: trial category, population age, and trial phase. CTIS Transition Deadline (31 January 2025): Less than 2 months remain until all ongoing trials must either end or transition to CTIS! Understanding these requirements is crucial for compliance. TrialScope Intelligence helps navigate disclosure rules across 193 countries with clear, comprehensive regulatory knowledge. Request a free demo today: https://ow.ly/lNtE50UnL7f _____ Follow Citeline Regulatory, giving you the information, tools and services needed to maintain clinical trial disclosure compliance, mitigate risk, and increase transparency.

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