Panalgo’s Post

Volume 5 of our popular #RWE use cases booklet series is here! Download it: https://ow.ly/ORBZ50TQeVM. As we've illustrated in four volumes of this booklet series, RWE's use in drug approvals by regulatory bodies like the FDA continues to expand. Manufacturers are not taking this lightly, as RWE supports more regulatory submissions yearly. This volume explores the most recent cases of RWE use for regulatory approvals from 2024. Download now!

Volume 5 of our popular #RWE use cases booklet series is here! Download it: https://ow.ly/yf9B50TR4fg. As we've illustrated in four volumes of this booklet series, RWE's use in drug approvals by regulatory bodies like the FDA continues to expand. Manufacturers are not taking this lightly, as RWE supports more regulatory submissions yearly. This volume explores the most recent cases of RWE use for regulatory approvals from 2024. Download now!

Volume 5 of our popular #RWE use cases booklet series is here! Download it: https://ow.ly/WQ5v50TR4k6. As we've illustrated in four volumes of this booklet series, RWE's use in drug approvals by regulatory bodies like the FDA continues to expand. Manufacturers are not taking this lightly, as RWE supports more regulatory submissions yearly. This volume explores the most recent cases of RWE use for regulatory approvals from 2024. Download now!

Uncover the power of SEND datasets in FDA compliance and drug development quality! In this guide, SEND Datasets FDA: Enhancing Compliance and Quality in Drug Development, you will learn how SEND datasets elevate your regulatory compliance game and ensure top-notch quality in drug development. Access the guide now and take your processes to the next level. https://hubs.la/Q02Dc7c70

Pharma Policy and What's Next? As pharma faces calls for greater transparency and competitive pricing, the implications are vast. PharmaVoice provides the latest on policy discussions that could reshape the landscape—from FDA and FTC regulations to drug pricing debates. Read the article: https://hubs.li/Q02XPw-50 #PharmaPolicy #DrugPricing #FDA #PharmaNews

Do you feel overwhelmed when it comes to your drug submission? Let me help you delve into all the complexities. 🚀 Take part in the latest 𝗦𝗖𝗛𝗢𝗧𝗧 𝗣𝗵𝗮𝗿𝗺𝗮𝘃𝗲𝗿𝘀𝗶𝘁𝘆® session and gain insights on streamlining your testing processes for regulatory compliance, accelerating your market submission, and elevating the assurance of your product’s quality and safety. Let's talk about considerations of electing a container in Early Clinical vs. Preparing Container Drug Submission. Why is building and maintaining solid expertise in testing activities for internal teams often difficult? How to turn the root cause into a solution? And how important are mistakes? I look forward to my webinar, What to test and what not to test, that is the question for your drug submission, on March 13th, 2024 | at 4:00 PM (CET). 👉 Sign up here: https://lnkd.in/dsTSps6A #pharmaversity #SCHOTTPharma #pharma

🌟 FDA’s ANDA Filing Guidelines: What You Need to Know! 🌟 For pharma professionals! The FDA guidelines for Abbreviated New Drug Applications (ANDAs) with MAPP 5200.14 Rev. 1, effective October 3, 2023. This update is set to make your filing reviews faster and more efficient. Key Highlights: Complete ANDA Checklist: Covers everything from Modules 1-5. Streamlined Procedures: Ensures smooth and efficient submissions. Enhanced Evaluation: Detailed guidance for drug substances and products. This is crucial for anyone in regulatory affairs, quality control, or drug development. Stay on top of these updates to ensure your ANDA submissions are top-notch. 🚀 Why It’s Important: Efficiency: Faster reviews. Compliance: Meet the latest standards. Quality: Ensure top safety and efficacy. 📥 Download the Full FDA MAPP 5200.14 Rev. 1 Document Stay informed and lead the way in pharma innovation! #PharmaIndustry #FDAUpdates #GenericDrugs #ANDA #RegulatoryAffairs

Facilities must be ready for inspection at the time of application submission to ensure timely assessment of original abbreviated new drug applications (ANDAs). FDA assigns a 15-month goal date for ANDAs if any facility is not ready for inspection, with the option to reset the goal date once all facilities become ready. Applicants should accurately assess and report facility readiness on Form FDA 356h to avoid delays in the goal date assignment process. This document provides guidance on how the FDA assigns goal dates for facility inspections as part of the Generic Drug User Fee Amendments (GDUFA). It explains that the FDA will defer substantive assessment of applications if facilities are not ready for inspection at the time of submission. The guidance outlines how applicants should assess and report facility readiness, and how the FDA will assign goal dates based on this information. It also explains the process for resetting goal dates if facilities become ready for inspection after the initial submission. The document emphasizes the importance of accurately reporting facility readiness to avoid delays in the approval process. Overall, the guidance aims to streamline the assessment process for generic drug applications. For more information, info@esthyalmodovar.com WhatsApp: https://lnkd.in/dz6U7tx5 #FDAreadiness #QualityBeyondGmp #biopharmaspain #biotecnología

Modernization Efforts Are Streamlining Regulatory Processes, FDA Report Finds: The seven-year effort to modernize FDA’s New Drugs Regulatory Program (NDRP) has paid off, with improvements in assessing drug approval applications, monitoring drug safety, operational efficiency and recruiting and retaining staff, according to a new CDER report. #fda #financial #lifesciences

𝐀 𝐒𝐭𝐫𝐚𝐭𝐞𝐠𝐢𝐜 𝐅𝐥𝐞𝐱𝐢𝐛𝐢𝐥𝐢𝐭𝐲: 𝐄𝐧𝐡𝐚𝐧𝐜𝐢𝐧𝐠 𝐅𝐚𝐜𝐢𝐥𝐢𝐭𝐲 𝐂𝐨𝐦𝐩𝐥𝐢𝐚𝐧𝐜𝐞 The FDA has finalized the facility readiness guidance (with no major changes from its draft version published in October 2022). By offering more time for facilities to achieve compliance with current good manufacturing practices (cGMP), the FDA aims to streamline the approval process and reduce delays caused by facility readiness issues. Under the Generic Drug User Fee Amendment (GDUFA III), sponsors of abbreviated new drug applications (ANDA) can receive a 15-month extension to bring non-compliant facilities up to standard. 𝘈𝘴 𝘴𝘵𝘢𝘵𝘦𝘥 𝘪𝘯 𝘵𝘩𝘦 𝘨𝘶𝘪𝘥𝘢𝘯𝘤𝘦, 𝘢𝘱𝘱𝘭𝘪𝘤𝘢𝘵𝘪𝘰𝘯𝘴 𝘴𝘵𝘪𝘭𝘭 𝘯𝘰𝘵 𝘳𝘦𝘢𝘥𝘺 𝘧𝘰𝘳 𝘪𝘯𝘴𝘱𝘦𝘤𝘵𝘪𝘰𝘯 30 𝘥𝘢𝘺𝘴 𝘣𝘦𝘧𝘰𝘳𝘦 𝘵𝘩𝘦 15-𝘮𝘰𝘯𝘵𝘩 𝘨𝘰𝘢𝘭 𝘥𝘢𝘵𝘦 𝘸𝘪𝘭𝘭 𝘩𝘢𝘷𝘦 𝘵𝘩𝘦𝘪𝘳 𝘢𝘴𝘴𝘦𝘴𝘴𝘮𝘦𝘯𝘵 𝘨𝘰𝘢𝘭 𝘳𝘦𝘴𝘦𝘵 𝘣𝘺 𝘢𝘯 𝘢𝘥𝘥𝘪𝘵𝘪𝘰𝘯𝘢𝘭 15 𝘮𝘰𝘯𝘵𝘩𝘴. 𝘛𝘩𝘪𝘴 𝘮𝘦𝘢𝘯𝘴 𝘢 𝘵𝘰𝘵𝘢𝘭 𝘱𝘰𝘵𝘦𝘯𝘵𝘪𝘢𝘭 𝘥𝘦𝘭𝘢𝘺 𝘰𝘧 30 𝘮𝘰𝘯𝘵𝘩𝘴, 𝘦𝘮𝘱𝘩𝘢𝘴𝘪𝘻𝘪𝘯𝘨 𝘵𝘩𝘦 𝘪𝘮𝘱𝘰𝘳𝘵𝘢𝘯𝘤𝘦 𝘰𝘧 𝘦𝘢𝘳𝘭𝘺 𝘤𝘰𝘮𝘱𝘭𝘪𝘢𝘯𝘤𝘦. While this extension is a positive step, it’s 𝘯𝘰𝘵 a blanket solution. The FDA has clarified that certain applications, particularly those involving 𝘣𝘪𝘰𝘦𝘲𝘶𝘪𝘷𝘢𝘭𝘦𝘯𝘤𝘦 𝘢𝘯𝘥 𝘤𝘭𝘪𝘯𝘪𝘤𝘢𝘭 𝘴𝘵𝘶𝘥𝘺 𝘧𝘢𝘤𝘪𝘭𝘪𝘵𝘪𝘦𝘴, 𝘰𝘳 𝘵𝘩𝘰𝘴𝘦 𝘵𝘩𝘢𝘵 𝘩𝘢𝘷𝘦 𝘢𝘭𝘳𝘦𝘢𝘥𝘺 𝘳𝘦𝘤𝘦𝘪𝘷𝘦𝘥 𝘤𝘰𝘮𝘱𝘭𝘦𝘵𝘦 𝘳𝘦𝘴𝘱𝘰𝘯𝘴𝘦 𝘰𝘳 𝘵𝘦𝘯𝘵𝘢𝘵𝘪𝘷𝘦 𝘢𝘱𝘱𝘳𝘰𝘷𝘢𝘭 𝘭𝘦𝘵𝘵𝘦𝘳𝘴, 𝘢𝘳𝘦 𝘯𝘰𝘵 𝘦𝘭𝘪𝘨𝘪𝘣𝘭𝘦 𝘧𝘰𝘳 𝘵𝘩𝘦 𝘥𝘦𝘧𝘦𝘳𝘳𝘢𝘭. This nuanced approach ensures that the focus remains on facilities crucial to the premarket application process. #FDA #Generics #GenericDrugs #RegulatoryAffairs #DrugApproval #FacilityReadiness #ANDA