📚 Mastering FDA Guidance Documents Keeping up with FDA guidance can be a challenge, but Basil Systems makes it easy. Our platform indexes and categorizes all FDA guidance documents, allowing you to quickly find the information you need for your device or regulatory needs. Set custom alerts to receive notifications when new guidance is released in topics relevant to you, ensuring your compliance strategies are always aligned with the latest regulatory updates. #FDAGuidance #RegulatoryIntelligence #MedTechCompliance #BasilSystems
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Quality is never measured by the thickness of a paper stack.
Just a reminder that the fact that we create extra source and worksheets is bonkers in most cases. From FDA guidance: https://lnkd.in/gzjMG3vW #clinicaltrials #clinicalresearch
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The 510(k)-submission process is a monumental milestone, but it's just the beginning. Our latest whitepaper by Michelle Hasse Richmond, an expert in FDA regulations, provides a comprehensive guide on what to expect after you've hit submit. Learn about the post-submission assessment, how to handle communication with the FDA, how to respond to deficiencies, and how to navigate post-approval considerations. Download 'What Happens After You Hit Submit: A Guide to Post-510(k) Actions' now. #MedicalDevices #IVD #FDA #RegulatoryCompliance #Whitepaper
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UPDATE (1/6/2025): FDA Interim Policy (final guidance) on Compounding using Bulk Drug Substances. 503A: https://lnkd.in/eGuN-Qwn 503B: https://lnkd.in/et3XBYxs Happy reading! :) #503A #503B #Compounding
FDA has been quite busy: two new 'guidance' documents for compounders "Interim Policy on Compounding Using Bulk Drug Substances Under Section 503A of the FDCA" & "Interim Policy on Compounding Using Bulk Drug Substances Under Section 503B of the FDCA".
Search for FDA Guidance Documents
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Stay ahead in the regulatory game! 📈 In February, the FDA published the QMSR Final Rule, a guideline designed to ensure medical device manufacturers adhere to high standards of quality and safety, promoting harmonization with ISO 13485:2016. Dive into our QMSR overview and discover expert tips on meeting compliance and deadlines. Ensure your success with RookQS as your partner in achieving QMSR compliance! #RegulatoryCompliance #MedicalDevices #QualityManagementSystems #LookToRook
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New FDA Guidance Coming! Stay Tuned for Thursday's Update!" Regulatory Update Alert! Is your business ready for the upcoming changes in FDA regulations? At Infinity Consulting Services, we stay ahead of the curve, bringing you the latest updates to ensure compliance and keep your business running smoothly. On Thursday, we’ll be sharing the latest changes that could impact on your industry. Stay tuned for insights and tips on how to navigate the new regulations! Mark your calendar! Check back on Thursday October 3, 2024, for the full update. #RegulatoryCompliance #FDAUpdates #ConsultingInsights #StayAhead
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Navigating through the FDA’s guidelines just got easier. ⚡ Whatfix transforms regulatory submissions with smart, intuitive solutions. It guides users seamlessly through complex forms, ensuring accuracy and adherence to FDA guidelines—every step of the way. Experience fewer rejections and enjoy significant time and cost savings with Whatfix. Curious to know exactly how? Check here 👇🏼 Know more: https://lnkd.in/gYGYpbYM #whatfix | #digitaladoption | #pharmaclickswithwhatfix
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The US FDA's latest guidance of September '24 on 'Providing Regulatory Submissions in Electronic Format,' outlines how sponsors and applicants should organize electronic submissions to the Agency under section 745A(a) of the FD&C Act. It references technical specification documents and the eCTD Guide for detailed organization requirements. This structured approach aims to enhance clarity, efficiency, and compliance in the submission process. Know more about the guidance from our experts. Schedule a meeting today. https://lnkd.in/gjtPYEAB #USFDAGuidance #RegulatorySubmissions #eCTD #PharmaReg #FreyrSolutions
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Check out our article “510(k) Preparation Pitfalls: Best Practices, FAQs, and Examples” for insights and practical advice to make your FDA approval journey more efficient. 📄 https://hubs.li/Q02QqxqB0 #MedicalDevices #HealthTech #MedicalSoftware #FDA #SaMD #SoftwareDevelopment #RAPSConvergence #RegulatoryCompliance
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Accelerating Life-Saving Therapies from Lab to Patient | Fueling Drug Innovation | Podcaster | Author | Speaker | Strategic Encourager
At #MedCon2024 the FDA is sharing some very helpful information on the latest updates, such as… After a thorough Compliance Program update completed with collaboration of the Center for Devices and Radiological Health (CDRH) and the Office of Regulatory Affairs (ORA)… FDA inspections will no longer be schedule-based (formerly every 2 years) but now are Risk-Based. It wasn’t tenable to maintain the schedule-based model with the number of device companies. #FDA #regulatorycompliance
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