Regulatory Transparency Project’s Post

In our last installment of our recent #GLP1 series, Union Healthcare Insight chief research officer Yulan Egan sums up the most important strategic implications of a new class of drugs upending the most important service lines in #healthcare. The truth is that no one really knows the extent of impact these drugs are likely to have, but we do know the parameters of that impact. We'd encourage all strategy leaders to create a version of the sliders below to see the threats and opportunities GLP-1s present to your own businesses. Read the linked blog post for more detail on where we see the current/future states of clinical and operational impact. And if you'd like us to bring that workshop to you, you know how to reach us. Like/repost/subscribe! https://lnkd.in/gj4UaNVX

Yulan Egan's final installment of Union Healthcare Insight's series on GLP-1 drugs--with handy strategic guide to help you figure out the long-term impact to your own business.

Biosimilars in the news! 📰 This week's top articles cover FDA approvals, new treatment possibilities, and current obstacles! Want to learn how biosimilars are making waves in health care? Click the link to dive in! https://lnkd.in/eP97dQDu

Picture this: an organization born over a century ago, evolving from a small bureau to a global influencer in public health. This is the story of the FDA, an agency that touches almost every aspect of our daily lives, often in ways we don't realize. 🎭 A Journey Through Time: Origin Story: The FDA's tale begins in 1906, aimed at curbing misleading food and drug labels. But did you know it was a scandalous book, 'The Jungle' by Upton Sinclair, highlighting the appalling conditions in the meatpacking industry, that spurred its creation? Evolving Mission: Today, the FDA's realm extends far beyond food and drugs. It's a guardian of public health, ensuring the safety and efficacy of a vast array of products – from the latest medical devices and therapies to the energy drinks you might have had this morning. Unexpected Twists: Regulating Surprises: The FDA's influence pops up in unexpected places. For instance, it regulates tobacco products and even the radiation-emitting screens you're using to read this post! Global Impact: Its decisions ripple across borders, shaping health policies and practices around the world. Balancing Act: Innovation vs. Safety: The FDA's most critical challenge? Balancing the need for rapid medical innovation with the paramount concern of safety and efficacy. So, here's a fun question for you: Can you guess any other surprising items or areas the FDA regulates? As we peel back the layers of this vital institution, we uncover a complex, fascinating world that goes far beyond mere regulations. Stay tuned for more eye-opening insights into the FDA and its pivotal role in medical devices and public health. #FDAFacts #BeyondRegulations #BiomedicalEngineering #PublicHealthInsights #medicaldevices #fda

Annex to previous posts (15May2024) Another report on the potential impacts on the US Healthcare System just in. The conclusions are insightful on at least 2 counts: a) offer an alternate strategic approach in forecasting "full value" and "effectiveness" prospectively and justify drug pricing in certain geographies that are conducive to such calculus, and b) the creation of precedent that potentially allows other willing parties to test the strategy with drug pricing/control.

The European Commission launched a public consultation on the cooperation with the European Medicines Agency under the Health Technology Assessment (HTA) Regulation. The proposed Implementing Act includes measures on: 📍Information-sharing 📍Joint clinical assessment/scientific consultations for devices and drugs 📍Patient identification and expert involvement in joint assessments 📍The protection of confidential information The public consultation will end on 24 July 2024 The Act is the third of six Implementing Acts undergoing public reviews > https://hubs.li/Q02DRtS-0 #HealthTech #RegulatoryFramework

The European Commission launched a public consultation on the cooperation with the European Medicines Agency under the Health Technology Assessment (HTA) Regulation. The proposed Implementing Act includes measures on: 📍Information-sharing 📍Joint clinical assessment/scientific consultations for devices and drugs 📍Patient identification and expert involvement in joint assessments 📍The protection of confidential information The public consultation will end on 24 July 2024 The Act is the third of six Implementing Acts undergoing public reviews > https://hubs.li/Q02DRlmV0 #HealthTech #RegulatoryFramework

I'm currently at a special meeting in Maryland, USA, where we're talking about following the rules in clinical research and making sure medicines are safe. This meeting is a great chance to learn about the latest rules, including what big health organizations think. We're discussing important things like keeping data safe and what health agencies will check in the future. This is a big deal in our industry! It's a great chance to show our product to the people who make the rules, to sponsors who might be interested, and to partner with companies who help with research. Big thanks to the FDA for putting together this important meeting! University of Maryland #fda #clinicaltrials #regulatorycompliance #mhra

Today marked the commencement of the ADA84 with the opening of the 84th Scientific Sessions by the Head of the FDA, Robert M. Califf. In his address, Califf underscored the FDA’s pivotal role in ensuring the safety and efficacy of pharmaceuticals and medical devices, safeguarding public health, and advancing regulatory science. He emphasized the critical importance of individual compliance, asserting it as the cornerstone for the successful implementation of health interventions and policy changes. While I concur with Califf’s perspective to a certain extent, the profound impact of weight loss medications observed recently raises a thought-provoking question. For centuries, recommendations centered around diet and exercise have not achieved the same level of efficacy as these new pharmacological interventions. This disparity prompts a significant debate: should we continue to rely predominantly on individual compliance, or should policymakers exert greater influence over our dietary and lifestyle choices to foster better health outcomes? #ADA84 #FDA #PublicHealth #WeightLossMedication #HealthPolicy #DietAndExercise #RegulatoryScience #IndividualCompliance #HealthDebate #ScientificSessions

Discover why a one-size-fits-all approach falls short in managing GLP-1 drug costs in our Analytics in Actions series. With a 320% surge in non-diabetic usage, our study reveals the challenges and expenses that comes with this. Learn why your organization needs enriched health data and expertise to navigate this quickly evolving landscape. #GLP1Costs #HealthcareAnalytics https://lnkd.in/eDYP94cV