Daniela Drago’s Post

𝗨𝗦 𝗙𝗗𝗔'𝘀 𝗢𝗻𝗰𝗼𝗹𝗼𝗴𝘆 𝗖𝗲𝗻𝘁𝗲𝗿 𝗼𝗳 𝗘𝘅𝗰𝗲𝗹𝗹𝗲𝗻𝗰𝗲 𝗣𝗿𝗼𝗷𝗲𝗰𝘁 𝗔𝘀𝗵𝗮 The US #FDA's Oncology Center of Excellence has launched Project Asha in partnership with the White House Cancer Moonshot Program to enhance oncology clinical trial access in India. The primary focus is to expand clinical trials, offer training for early career researchers, provide regulatory guidance, and improve patient-centered approaches in low-resource settings with support from Indian pharmaceuticals. Project Asha will also foster international research collaborations, ensuring inclusive participation and robust privacy protections. Despite India's large population representing nearly 20% of the global total, only 1.5% of worldwide clinical trials are conducted there. Addressing this disparity, Project Asha aims not only to improve health outcomes in India but also to enhance global cancer research. #Oncology #ClinicalTrials #GlobalHealth #CancerCare

𝗘𝗨 𝗣𝗮𝗿𝗹𝗶𝗮𝗺𝗲𝗻𝘁 𝗔𝗱𝗼𝗽𝘁𝘀 𝗟𝗮𝗻𝗱𝗺𝗮𝗿𝗸 𝗣𝗵𝗮𝗿𝗺𝗮𝗰𝗲𝘂𝘁𝗶𝗰𝗮𝗹 𝗥𝗲𝗳𝗼𝗿𝗺𝘀 𝗔𝗺𝗶𝗱 𝗜𝗻𝗱𝘂𝘀𝘁𝗿𝘆 𝗖𝗼𝗻𝗰𝗲𝗿𝗻𝘀 This week, the European Parliament has voted to adopt a significant update to the EU's pharmaceutical regulations, the first in 20 years. By a substantial majority, the Parliament adopted new legislation that seeks to balance drugmaker incentives and medication access. The pharmaceutical industry expressed concerns that the changes might stifle innovation by reducing incentives, especially in areas like orphan drug and pediatric medication development. The new Parliament will revisit the legislation post the June 6-9 European elections, and the European Council must endorse the package before final negotiations can proceed. #drugdevelopment #biopharma #regulatoryaffairs

𝗥𝗲𝗮𝗹-𝗧𝗶𝗺𝗲 𝗢𝗻𝗰𝗼𝗹𝗼𝗴𝘆 𝗥𝗲𝘃𝗶𝗲𝘄 (𝗥𝗧𝗢𝗥) Have you wondered 𝘸𝘩𝘢𝘵 𝘪𝘴 𝘵𝘩𝘦 𝘍𝘋𝘈'𝘴 𝘖𝘯𝘤𝘰𝘭𝘰𝘨𝘺 𝘊𝘦𝘯𝘵𝘦𝘳 𝘰𝘧 𝘌𝘹𝘤𝘦𝘭𝘭𝘦𝘯𝘤𝘦 𝘙𝘦𝘢𝘭-𝘛𝘪𝘮𝘦 𝘖𝘯𝘤𝘰𝘭𝘰𝘨𝘺 𝘙𝘦𝘷𝘪𝘦𝘸 (𝘙𝘛𝘖𝘙) 𝘱𝘳𝘰𝘨𝘳𝘢𝘮? In this short video, I answer this question. #drugdevelopment #pharmaceuticals #biopharma #regulatoryaffairs ____________________________________ 𝘉𝘦𝘭𝘪𝘦𝘷𝘦 𝘺𝘰𝘶𝘳 𝘯𝘦𝘵𝘸𝘰𝘳𝘬 𝘮𝘪𝘨𝘩𝘵 𝘧𝘪𝘯𝘥 𝘵𝘩𝘪𝘴 𝘷𝘢𝘭𝘶𝘢𝘣𝘭𝘦? 𝘏𝘪𝘵 𝘳𝘦𝘱𝘰𝘴𝘵 𝘞𝘢𝘯𝘵 𝘵𝘰 𝘸𝘰𝘳𝘬 𝘵𝘰𝘨𝘦𝘵𝘩𝘦𝘳? 𝘏𝘦𝘳𝘦 𝘪𝘴 𝘢 𝘭𝘪𝘯𝘬 𝘵𝘰 𝘴𝘤𝘩𝘦𝘥𝘶𝘭𝘦 𝘢 𝘤𝘢𝘭𝘭: https://rb.gy/dizmuu

I am looking forward to speaking at the 𝘐𝘯𝘵𝘳𝘰𝘥𝘶𝘤𝘵𝘪𝘰𝘯 𝘵𝘰 𝘋𝘳𝘶𝘨 𝘓𝘢𝘸 𝘢𝘯𝘥 𝘙𝘦𝘨𝘶𝘭𝘢𝘵𝘪𝘰𝘯 course offered by the Food and Drug Law Institute (FDLI) on April 24–25, 2024, in Washington, DC. Spots are filling fast, but there’s still time to secure your seat. Join us for an insightful journey into the world of drug regulation!   #drugdevelopment  #biopharma #druglaw #drugregulation https://lnkd.in/eJrasM8C

𝗧𝗵𝗲 𝗦𝗽𝗹𝗶𝘁 𝗥𝗲𝗮𝗹 𝗧𝗶𝗺𝗲 𝗔𝗽𝗽𝗹𝗶𝗰𝗮𝘁𝗶𝗼𝗻 𝗥𝗲𝘃𝗶𝗲𝘄 (𝗦𝗧𝗔𝗥) 𝗣𝗶𝗹𝗼𝘁 𝗣𝗿𝗼𝗴𝗿𝗮𝗺 Have you wondered 𝘸𝘩𝘢𝘵 𝘪𝘴 𝘵𝘩𝘦 𝘍𝘋𝘈'𝘴 𝘚𝘱𝘭𝘪𝘵 𝘙𝘦𝘢𝘭 𝘛𝘪𝘮𝘦 𝘈𝘱𝘱𝘭𝘪𝘤𝘢𝘵𝘪𝘰𝘯 𝘙𝘦𝘷𝘪𝘦𝘸 (𝘚𝘛𝘈𝘙) 𝘱𝘪𝘭𝘰𝘵 𝘱𝘳𝘰𝘨𝘳𝘢𝘮? In this short video, I answer this question. #drugdevelopment #pharmaceuticals #biopharma #regulatoryaffairs ____________________________________ 𝘉𝘦𝘭𝘪𝘦𝘷𝘦 𝘺𝘰𝘶𝘳 𝘯𝘦𝘵𝘸𝘰𝘳𝘬 𝘮𝘪𝘨𝘩𝘵 𝘧𝘪𝘯𝘥 𝘵𝘩𝘪𝘴 𝘷𝘢𝘭𝘶𝘢𝘣𝘭𝘦? 𝘏𝘪𝘵 𝘳𝘦𝘱𝘰𝘴𝘵 𝘞𝘢𝘯𝘵 𝘵𝘰 𝘸𝘰𝘳𝘬 𝘵𝘰𝘨𝘦𝘵𝘩𝘦𝘳? 𝘏𝘦𝘳𝘦 𝘪𝘴 𝘢 𝘭𝘪𝘯𝘬 𝘵𝘰 𝘴𝘤𝘩𝘦𝘥𝘶𝘭𝘦 𝘢 𝘤𝘢𝘭𝘭: https://rb.gy/dizmuu

𝗥𝗮𝗰𝗲 𝗔𝗴𝗮𝗶𝗻𝘀𝘁 𝗧𝗶𝗺𝗲: 𝗘𝗠𝗔 𝗖𝗮𝗹𝗹𝘀 𝗳𝗼𝗿 𝗖𝗧𝗜𝗦 𝗦𝘂𝗯𝗺𝗶𝘀𝘀𝗶𝗼𝗻𝘀 𝗔𝗵𝗲𝗮𝗱 𝗼𝗳 𝟮𝟬𝟮𝟱 𝗗𝗲𝗮𝗱𝗹𝗶𝗻𝗲! The European Medicines Agency (EMA) continues to urge sponsors to promptly submit their clinical trial applications to the Clinical Trials Information System (CTIS) to avoid missing the 30 January 2025 deadline. At a recent meeting of the EMA Management Board, officials said that 20% of trials transitioned to CTIS. With the authorization process taking up to three months, early action is key. The Agency has enhanced CTIS transparency and simplified processes for data protection, aiming for efficient platform use by all stakeholders. #drugdevelopment #clinicaltrials #regulatoryaffairs #biopharma

𝗘𝘂𝗿𝗼𝗽𝗲𝗮𝗻 𝗥𝗲𝗴𝘂𝗹𝗮𝘁𝗼𝗿𝘆 𝗣𝗮𝘁𝗵𝘄𝗮𝘆 𝗦𝗶𝗺𝗶𝗹𝗮𝗿 𝘁𝗼 𝘁𝗵𝗲 𝗨𝗦 𝗙𝗗𝗔’𝘀 𝟱𝟬𝟱(𝗯)𝟮 Have you wondered 𝘥𝘰𝘦𝘴 𝘌𝘶𝘳𝘰𝘱𝘦 𝘩𝘢𝘷𝘦 𝘢 𝘳𝘦𝘨𝘶𝘭𝘢𝘵𝘰𝘳𝘺 𝘱𝘢𝘵𝘩𝘸𝘢𝘺 𝘴𝘪𝘮𝘪𝘭𝘢𝘳 𝘵𝘰 𝘵𝘩𝘦 𝘜𝘚 𝘍𝘋𝘈’𝘴 505(𝘣)2? In this short video, I answer this question. #drugdevelopment #pharmaceuticals #biopharma #regulatoryaffairs ____________________________________ 𝘉𝘦𝘭𝘪𝘦𝘷𝘦 𝘺𝘰𝘶𝘳 𝘯𝘦𝘵𝘸𝘰𝘳𝘬 𝘮𝘪𝘨𝘩𝘵 𝘧𝘪𝘯𝘥 𝘵𝘩𝘪𝘴 𝘷𝘢𝘭𝘶𝘢𝘣𝘭𝘦? 𝘏𝘪𝘵 𝘳𝘦𝘱𝘰𝘴𝘵 𝘞𝘢𝘯𝘵 𝘵𝘰 𝘸𝘰𝘳𝘬 𝘵𝘰𝘨𝘦𝘵𝘩𝘦𝘳? 𝘏𝘦𝘳𝘦 𝘪𝘴 𝘢 𝘭𝘪𝘯𝘬 𝘵𝘰 𝘴𝘤𝘩𝘦𝘥𝘶𝘭𝘦 𝘢 𝘤𝘢𝘭𝘭: https://rb.gy/dizmuu

The #FDA issued a new draft guidance on Real-World Evidence: Considerations Regarding Non-Interventional Studies. The document includes approaches to attributes of study design, data sources, and analyses. #drugdevelopment #regulatoryaffairs #biopharma

𝗧𝗵𝗲 𝗣𝗮𝘀𝘁, 𝗣𝗿𝗲𝘀𝗲𝗻𝘁, 𝗮𝗻𝗱 𝗙𝘂𝘁𝘂𝗿𝗲 𝗼𝗳 𝗢𝗻𝗰𝗼𝗹𝗼𝗴𝘆 𝗔𝗱𝘃𝗶𝘀𝗼𝗿𝘆 𝗖𝗼𝗺𝗺𝗶𝘁𝘁𝗲𝗲𝘀 There is still time to register! At 9:30 am ET on March 19, 2024, the US #FDA will host a 𝘊𝘰𝘯𝘷𝘦𝘳𝘴𝘢𝘵𝘪𝘰𝘯 𝘰𝘯 𝘊𝘢𝘯𝘤𝘦𝘳 focusing on the role of the Oncologic Drugs Advisory Committee (ODAC) in the regulatory process.    A panel of ODAC members and regulators will provide insights on considerations for member selection and ODAC meetings’ preparation. Panelists will discuss: 🔹 ODAC composition and planning  🔹 Topics that are brought to ODAC  🔹 Oncology Center of Excellence’s efforts to streamline ODAC  🔹 Experiences from current and past ODAC members and chairs The virtual meeting is free and open to the public, but registration is required. Here is a link to more information and instructions on how to register: https://lnkd.in/e2s4D-RM #drugdevelopment #regulatoryaffairs #biopharma #oncology

𝗖𝗹𝗶𝗻𝗶𝗰𝗮𝗹 𝗧𝗿𝗶𝗮𝗹 𝗩𝗮𝗹𝗶𝗱𝗶𝘁𝘆 Have you wondered 𝘸𝘩𝘢𝘵 𝘪𝘴 𝘵𝘩𝘦 𝘷𝘢𝘭𝘪𝘥𝘪𝘵𝘺 𝘰𝘧 𝘢 𝘤𝘭𝘪𝘯𝘪𝘤𝘢𝘭 𝘴𝘵𝘶𝘥𝘺? In this short video, I answer this question. #drugdevelopment #pharmaceuticals #biopharma #regulatoryaffairs #clinicaltrials ____________________________________ 𝘉𝘦𝘭𝘪𝘦𝘷𝘦 𝘺𝘰𝘶𝘳 𝘯𝘦𝘵𝘸𝘰𝘳𝘬 𝘮𝘪𝘨𝘩𝘵 𝘧𝘪𝘯𝘥 𝘵𝘩𝘪𝘴 𝘷𝘢𝘭𝘶𝘢𝘣𝘭𝘦? 𝘏𝘪𝘵 𝘳𝘦𝘱𝘰𝘴𝘵 𝘞𝘢𝘯𝘵 𝘵𝘰 𝘸𝘰𝘳𝘬 𝘵𝘰𝘨𝘦𝘵𝘩𝘦𝘳? 𝘏𝘦𝘳𝘦 𝘪𝘴 𝘢 𝘭𝘪𝘯𝘬 𝘵𝘰 𝘴𝘤𝘩𝘦𝘥𝘶𝘭𝘦 𝘢 𝘤𝘢𝘭𝘭: https://rb.gy/dizmuu