National Health Executive’s Post

The U.S. Food and Drug Administration has published final guidance on “Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products” (SIUU Guidance), which describes permitted dissemination of scientific information on unapproved uses of approved/cleared medical products by firms to healthcare providers. The updated guidance finalizes FDA’s proposed approach from its 2023 draft guidance, with notable revisions in response to industry and public criticism of the draft. Read more here: https://lnkd.in/esBsETp8 Authors: Jodi Scott, Komal Karnik Nigam, Suzanne Levy Friedman, Sally Gu, Katie Kramer, Gabrielle Simeck, and Evelyn Tsisin #FDA #HCPs #SIUUGuidance

🌍 New Publication Alert! 🌍 We are excited to share a new #SouthViews article by Nirmalya Syam analysing the implications of the US Affordable Prescription for Patients Act (S-150) and how similar legislative measures can improve access to affordable medicines in developing countries. 📖 Read the full article here: https://lnkd.in/gnfpjZ-K 🔍 Key insights include: - Strengthening patent review processes to prevent patent thickets. - Encouraging biosimilar competition for affordable medicines. - Adopting TRIPS flexibilities to balance patents and public health. - Collaborative approaches among Global South countries for joint strategies. Whether you're a policy maker, healthcare professional, or interested in global health issues, this is a must-read! #Healthcare #GlobalSouth #PatentLaw #AffordableMedicines #Pharmaceuticals #PublicHealth #PolicyReform

Prem-editative Pharma : Value Chain Weekly Series #02 - Constitutional Imperatives PharmaValueChain# 02 In the complex landscape of the pharmaceutical supply chain, constitutional mandates such as Article 21, 19(g), and 47 play a crucial role in ensuring ethical and efficient medicine delivery, promoting public health, and ensuring access to essential medications. 📜Article 21 - Access to Life-Saving Drugs: 💡For People: Ensures timely access to essential medicines for peace of mind and health security. 💼 For Pharma Companies: Enhances market credibility and fosters trust among stakeholders. 📜Article 19(g) - Freedom in Supply Chain Practices: 💡For People: Ensures reliable access to healthcare resources through individual contributions to the smooth flow of medicines. 💼 For Pharma Companies: Empowers individuals to contribute to efficient flow and accessibility of pharmaceutical products. 📜Article 47 - Public Health Prioritization: 💡For People: Underlines the commitment to providing safe and affordable medicines, ensuring community well-being. 💼 For Pharma Companies: Shapes ethical delivery of pharmaceutical products, fostering trust and long-term sustainability. Exploring the intersection of constitutional mandates and the pharmaceutical supply chain—empowering ethics, accessibility, and public health. Keep it tied for our weekly chain, where pharma ponders with impact! We're all about your suggestions, and we've got a lot of updates in the backlog too! #PremsParlour #PremeditativePharma #Science #PublicHealth 🔗Reference: - Constitution of India - Legislative Department: https://lnkd.in/gBPkyz-Y - Wikipedia: https://lnkd.in/gydiGHXC

Is the FDA the Gold Standard? A Global Perspective on Drug Approval The FDA has long been considered the gold standard for drug approval. However, the WHO SRA Collaborative Registration Procedure (CRP) offers a compelling alternative, particularly for global health equity. Here's why the CRP deserves more attention: * Global Focus: Prioritizes diverse populations, especially in low- and middle-income countries. * Collaborative Approach: Leverages expertise from multiple stringent regulatory authorities. * Equity-Centered: Improves access to essential medicines in resource-limited settings. * Broader Data Consideration: Adapts to varied healthcare contexts. * Efficiency: Reduces time and cost for approvals, especially in resource-constrained regions. * Sovereignty with Support: Empowers national regulatory authorities while leveraging global expertise. * Public Health Priorities: Focuses on neglected diseases and pandemic preparedness. * Transparency and Collaboration: Fosters open sharing of evaluations among stakeholders. * Adaptability: Can quickly respond to global health emergencies. * Proven Results: Has accelerated access to essential medicines in over 23 countries. Let's discuss: * Do you believe the CRP is a more effective model for global drug approval? * What are the potential challenges and limitations of the CRP? * How can we further strengthen international collaboration in drug regulation? #globalhealth #drugregulation #WHO #FDA #publichealth #healthcare #pharma #biotech

Ethics are the cornerstone of responsible research. 🏛️ Participant safety is always the top priority, with every study designed to meet the highest standards of care. ✅ Informed decision-making is fully respected, and personal information is kept secure and confidential. 🔒 Each study undergoes rigorous review to ensure it is safe, fair, and transparent. 🔍 Trust is invaluable, and earning it is essential at every step of the research process. 🩺 Medcare Pharma: Your Way to Cure Contact us: ☎️ | 1-866-4-MEDICINE 📧 | info@medcarepharma.care 🌐 | https://lnkd.in/gA9pPUVR #clinicaltrialsupport #pharmacy #clinicaltrial #clinicalresearch #medicalresearch #clinicalstudies #clinicalstudy #healthcare #medcarepharma #researchstudies

The U.S. Food and Drug Administration has published final guidance on “Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products” (SIUU Guidance), which describes permitted dissemination of scientific information on unapproved uses of approved/cleared medical products by firms to healthcare providers. The updated guidance finalizes FDA’s proposed approach from its 2023 draft guidance, with notable revisions in response to industry and public criticism of the draft.

The new EU HTA regulation demands more from drug developers—regulatory and HTA processes will now run in parallel. This presents a critical challenge: how do you optimize your teams to manage both without compromising efficiency? In our last webinar, Chantal W.M. van Gils and Maxwell Craig discuss why breaking down silos between clinical development, regulatory, and market access teams is vital for success. Watch the full webinar to learn how to stay ahead. https://lnkd.in/d9B74_Zq At SSI Strategy, we partner with you to develop an evidence and value strategy that meets these new requirements head-on. Don’t let resource misalignment slow your path to market. Let's talk! letstalk@ssistrategy.com

📢 Update from the FDA! 📢 The FDA has issued a final guidance regarding Real-World Evidence (RWE), where it provides sponsors and other interested parties with considerations for leveraging electronic health records (EHRs) and medical claims data to support a regulatory decision for effectiveness or safety. 🔍 What does this mean for the Life Sciences industry? This guidance marks a significant step forward in utilizing real-world data to enhance regulatory decision-making. The hope is that it may open new avenues for innovation, so that the benefits of leading-edge therapies can reach patients more efficiently and effectively. By harnessing RWE, we can accelerate the development of safe and effective treatments, ultimately improving patient outcomes and advancing health and wellness as a whole. We are excited to see how the potential of real-world data will impact drug development and regulatory processes. 🌐💡 To learn more about our drug development consulting services, visit: https://lnkd.in/ghJ5zTNh To learn more about our how we could support your regulatory planning and submissions process, visit: https://lnkd.in/gQzZcFUT #FDA #Regulatory #RealWorldData #Innovation #LifeSciences https://lnkd.in/geANjjW7

Did you know that medicines are the largest source of expenditure for most medical institutions, second only to human resources? 💊 💉 📈 Across the #Commonwealth, pharmacists have both a unique expertise to offer and a critical role to play in developing more resilient, sustainable and equitable medicine distribution systems - especially at a time when medicines are becoming more costly across the world. That's why today our CEO Victoria Rutter and Trustee Zaheer-Ud-Din Babar led a webinar on pharmaceutical pricing for the Commonwealth Heads of Procurement Network (HOPN), with roundtable discussion moderated by Commonwealth Secretariat Health Advisor Janneth Mghamba. Professor Babar is a world-leading expert in pharmaceutical policy and pricing with more than 300 papers to his name. Our HOPN webinars bring together leaders in medicine procurement and storage from across the Commonwealth to discuss shared challenges and share best practice for increasing equitable access to essential medicines, providing vital context and learning to help shape decisions that impact the lives of patients around the Commonwealth. #pharmacy #CPApharm #health #healthcare #medicine #pharma

On 21st October 2024, the National Medical Products Administration issued the Pilot Program for Segmented Production of Biological Products (“Pilot Program”) with immediate effect. Applicants for drug registration and MAHs shall submit its application to the provincial medical product administration by 31st December 2025. Nicolas Zhu and Laila Lu provided a summary of the Pilot Program. Please see our newsletter here: https://lnkd.in/d7kCqqg5 #cmslaw #lifesciences #healthcare #PilotProgram #SegmentedProductionofBiologicalProducts