BIOBOSTON CONSULTING

𝗧𝗼𝗽 𝟱 𝗖𝗵𝗮𝗹𝗹𝗲𝗻𝗴𝗲𝘀 𝗶𝗻 𝗗𝗿𝘂𝗴 𝗥𝗲𝗽𝘂𝗿𝗽𝗼𝘀𝗶𝗻𝗴: 𝗪𝗵𝘆 𝗢𝗻𝗹𝘆 𝟭𝟱% 𝗼𝗳 𝗧𝗿𝗶𝗮𝗹𝘀 𝗦𝘂𝗰𝗰𝗲𝗲𝗱 https://lnkd.in/ebSMw7-r 𝗦𝗰𝗵𝗲𝗱𝘂𝗹𝗲 𝗮 𝗰𝗼𝗻𝘀𝘂𝗹𝘁𝗮𝘁𝗶𝗼𝗻👉https://lnkd.in/e52sdG3P Contact BIOBOSTON CONSULTING today or visit our website at https://lnkd.in/dfarwCK2 to learn more about how we can support your organization. #compliance #quality #regulatory #clinical #pharmaceutical #biotechnology #consulting #fda

𝗙𝗗𝗔 𝗔𝗽𝗽𝗿𝗼𝘃𝗲𝘀 𝗘𝗹𝗶 𝗟𝗶𝗹𝗹𝘆’𝘀 𝗗𝗼𝗻𝗮𝗻𝗲𝗺𝗯 𝘁𝗼 𝗧𝗿𝗲𝗮𝘁 𝗔𝗹𝘇𝗵𝗲𝗶𝗺𝗲𝗿’𝘀 𝗗𝗶𝘀𝗲𝗮𝘀𝗲 𝗧𝗮𝗹𝗸 𝘄𝗶𝘁𝗵 𝗮𝗻 𝗲𝘅𝗽𝗲𝗿𝘁 👉https://lnkd.in/e52sdG3P 🔹 The FDA has approved Eli Lilly's donanemab, an anti-amyloid antibody marketed as Kisunla, making it the third drug approved to modify the course of Alzheimer’s disease. This approval follows the previously approved anti-amyloid antibodies, Biogen and Eisai’s Aduhelm, and Leqembi, which has been commercially successful. The FDA's decision, supported by a favorable advisory committee vote, underscores the positive stance on donanemab despite concerns over trial design and safety, particularly amyloid-related imaging abnormalities (ARIA). 🔹Experts anticipate that donanemab’s approval will benefit the broader market, including Leqembi, by enhancing diagnostic and treatment options for Alzheimer’s disease. Contact BIOBOSTON CONSULTING today or visit our website at https://lnkd.in/dfarwCK2 to learn more about how we can support your organization. #compliance #quality #regulatory #clinical #pharmaceutical #biotechnology #consulting #fda

𝗣𝗿𝗶𝘃𝗮𝗰𝘆 𝘃𝘀. 𝗢𝗽𝗲𝗻𝗻𝗲𝘀𝘀: 𝗧𝗵𝗲 𝗗𝗮𝘁𝗮 𝗗𝗶𝗹𝗲𝗺𝗺𝗮 𝗖𝗼𝗻𝘁𝗮𝗰𝘁 𝗨𝘀 👉https://lnkd.in/e52sdG3P Contact BIOBOSTON CONSULTING today or visit our website at https://lnkd.in/dfarwCK2 to learn more about how we can support your organization. #compliance #quality #regulatory #clinical #pharmaceutical #biotechnology #consulting #fda

𝗧𝗼𝗽 𝟱 𝗔𝗹𝗮𝗿𝗺𝗶𝗻𝗴 𝗦𝘁𝗮𝘁𝘀 𝗬𝗼𝘂 𝗡𝗲𝗲𝗱 𝘁𝗼 𝗞𝗻𝗼𝘄 𝗔𝗯𝗼𝘂𝘁 𝗣𝗿𝗶𝘃𝗮𝗰𝘆 𝘃𝘀. 𝗢𝗽𝗲𝗻𝗻𝗲𝘀𝘀 https://lnkd.in/eH_VVmvR 𝗧𝗮𝗹𝗸 𝘄𝗶𝘁𝗵 𝗮𝗻 𝗲𝘅𝗽𝗲𝗿𝘁 👉https://lnkd.in/e52sdG3P Contact BIOBOSTON CONSULTING today or visit our website to learn more about how we can support your organization. https://lnkd.in/dfarwCK2 #compliance #quality #regulatory #clinical #pharmaceutical #biotechnology #consulting #fda

𝟱 𝗞𝗲𝘆 𝗦𝘁𝗿𝗮𝘁𝗲𝗴𝗶𝗲𝘀 𝘁𝗼 𝗖𝗼𝗺𝗺𝘂𝗻𝗶𝗰𝗮𝘁𝗲 𝗩𝗮𝗹𝘂𝗲 𝗶𝗻 𝗕𝗶𝗼𝘁𝗲𝗰𝗵 𝗜𝗻𝘃𝗲𝘀𝘁𝗼𝗿 𝗥𝗲𝗹𝗮𝘁𝗶𝗼𝗻𝘀 https://lnkd.in/ekKmCfM3 𝗖𝗼𝗻𝘁𝗮𝗰𝘁 𝗨𝘀 👉https://lnkd.in/e52sdG3P Contact BIOBOSTON CONSULTING today or visit our website at https://lnkd.in/dfarwCK2 to learn more about how we can support your organization. #compliance #quality #regulatory #clinical #pharmaceutical #biotechnology #consulting #fda

𝗠𝟭𝟰 𝗚𝗲𝗻𝗲𝗿𝗮𝗹 𝗣𝗿𝗶𝗻𝗰𝗶𝗽𝗹𝗲𝘀 𝗼𝗻 𝗣𝗹𝗮𝗻, 𝗗𝗲𝘀𝗶𝗴𝗻, 𝗮𝗻𝗱 𝗔𝗻𝗮𝗹𝘆𝘀𝗶𝘀 𝗼𝗳 𝗣𝗵𝗮𝗿𝗺𝗮𝗰𝗼𝗲𝗽𝗶𝗱𝗲𝗺𝗶𝗼𝗹𝗼𝗴𝗶𝗰𝗮𝗹 𝗦𝘁𝘂𝗱𝗶𝗲𝘀 𝗖𝗼𝗻𝘁𝗮𝗰𝘁 𝗨𝘀 📞 https://lnkd.in/e52sdG3P 🔹 Pharmacoepidemiological studies are a branch of epidemiology that focus on understanding the use, effectiveness, and safety of pharmaceuticals in large, well-defined populations. These studies apply the principles and methods of epidemiology to the content area of clinical pharmacology, thus bridging the gap between clinical research and public health. 🔹This guidance provides comprehensive principles on the planning, design, and analysis of pharmacoepidemiological studies that utilize real-world data (RWD) for assessing the safety of medicines. The aim is to ensure that such studies are robust, reliable, and provide meaningful safety information. 🔹 This draft guidance provides general guidelines for planning, designing, and analyzing observational (noninterventional) pharmacoepidemiological studies for assessing the safety of medicines (drugs, vaccines, and other biological products) by utilizing fit-for-purpose data. This draft guidance includes high-level best practices and recommendations for conducting these studies. 🔹 This draft guidance aims to streamline the development of postmarketing pharmacoepidemiological safety studies that incorporate Real-World Data and the regulatory assessment of those studies. As part of this guidance, health authorities will be more likely to accept study protocols and/or results and support decision-making in response to study results. 🔹 The M14 guideline underscores the importance of rigorously designed and conducted pharmacoepidemiological studies using RWD for drug safety assessment. Adhering to these principles enhances the reliability and validity of study findings, ultimately contributing to improved patient safety and public health outcomes. Download the guidance here: https://lnkd.in/emnPG43v Contact BIOBOSTON CONSULTING today or visit our website to learn more about how we can support your organization. #compliance #quality #regulatory #clinical #pharmaceutical #biotechnology #consulting #fda

🚨 URGENT ALERT: Warning Letter!! Compliance Crisis in the E-Cig Industry!🚨 The FDA has issued a Warning Letter to Ecig Charleston LLC for manufacturing and selling e-liquid products without the required marketing authorization. 🛑 This isn't just about one company—this is a wake-up call for the entire industry. 🚬💻 Some companies forget that All e-liquid products must comply with FDA regulations, and Nicotine products from any source fall under FDA jurisdiction. Non-compliance can lead to severe penalties, including seizures and injunctions. Warning letter 👉https://lnkd.in/eeRWWK7J 👉 What are your thoughts on this crackdown? Do you think the FDA's actions are justified? Let's discuss in the comments! 👇 #FDA #eCig #Compliance #Health #Regulation #pharmaceuticals #biotechnology

🚀 Exciting Update from the FDA! 🚀How do you think this will impact the industry? Let's discuss! 💬 The FDA has released the final guidance for industry: “Providing Regulatory Submissions in Electronic Format: IND Safety Reports.” This finalizes the draft guidance published on October 30, 2019. It outlines the required electronic format for submitting IND safety reports to CDER and CBER for serious and unexpected suspected adverse reactions, as mandated under 21 CFR 312.32(c)(1)(i). These electronic format requirements are established under section 745A(a) of the FD&C Act (21 U.S.C. 379k-1(a)). 💡 Your thoughts and comments are welcome! How do you think this will impact the industry? Let's discuss! 💬 #FDA #Guidance #Regulatory #HealthcareInnovation #IndustryNews #pharmaceuticals #biotechnology #biotech

𝟱 𝗞𝗲𝘆 𝗦𝘁𝗿𝗮𝘁𝗲𝗴𝗶𝗲𝘀 𝘁𝗼 𝗖𝗼𝗺𝗺𝘂𝗻𝗶𝗰𝗮𝘁𝗲 𝗩𝗮𝗹𝘂𝗲 𝗶𝗻 𝗕𝗶𝗼𝘁𝗲𝗰𝗵 𝗜𝗻𝘃𝗲𝘀𝘁𝗼𝗿 𝗥𝗲𝗹𝗮𝘁𝗶𝗼𝗻𝘀 https://lnkd.in/ekKmCfM3 𝗧𝗮𝗹𝗸 𝘄𝗶𝘁𝗵 𝗮𝗻 𝗲𝘅𝗽𝗲𝗿𝘁 👉https://lnkd.in/e52sdG3P Contact BIOBOSTON CONSULTING today or visit our website at https://lnkd.in/dfarwCK2 to learn more about how we can support your organization. #compliance #quality #regulatory #clinical #pharmaceutical #biotechnology #consulting #fda