Staying current with FDA guidance is essential for innovators and those embarking on their approval journey. Guidances provide insight and clarity. Think of them as a tool or playbook for understanding regulatory expectations. Stay informed and stay current, to help ease your path to approval. #FDA #Innovation #RegulatoryCompliance #HealthcareInnovation #ApprovalJourney #TrueNorth #TrueNorthContractResearch True North Contract Research Keeley Puls-Boever Travis Holman
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Turn your pre-IND meeting into a strategic advantage and set the stage for a smooth regulatory journey. Here are essential tips on key discussion points, effective communication strategies, and aligning your development plan with FDA expectations: https://hubs.ly/Q02Cd_0m0 #clinicaltrials #clinicalresearch #drugdevelopment
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🎤 Join our expert panel, including Peter Marks from the FDA, to discuss the future of the FDA Accelerated Approval Program. Register here: https://bit.ly/48aiWE3 #FDAApproval #HealthPolicy #PatientOutcomes
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🎤 Join our expert panel, including Peter Marks from the FDA, to discuss the future of the FDA Accelerated Approval Program. Register here: https://bit.ly/48aiWE3 #FDAApproval #HealthPolicy #PatientOutcomes
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🎤 Join our expert panel, including Peter Marks from the FDA, to discuss the future of the FDA Accelerated Approval Program. Register here: https://bit.ly/48aiWE3 #FDAApproval #HealthPolicy #PatientOutcomes
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The FDA has released a draft guidance titled "Accelerated Approval and Considerations for Determining Whether a Confirmatory Trial is Underway." Once finalized, this guidance will outline the FDA’s interpretation of the term "underway" and its policies for enforcing this requirement. It will also detail the factors the FDA will consider when assessing whether a confirmatory trial is in progress before taking an accelerated approval action. #fda #medtech #regulatoryaffairs #regulatorycompliance #fdaaproval #medicaldeviceregulation https://lnkd.in/ehAMHASQ
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In the second installment of this three-part blog series, "Navigating an FDA Meeting – Best Practices for Maximizing Your Time and Effort," Eric Hardter, Ph.D., RAC (US, CAN, EU) provides an in-depth exploration of two crucial aspects: Building your submission documentation and establishing a regulatory timeline. Read the blog here: https://lnkd.in/ejabPg9i or get in touch with one of our award-winning regulatory experts for personalized support in preparing for your FDA meeting, contact info@boydconsultants.com. #FDA #RegulatoryAffairs #preIND
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In the second installment of this three-part blog series, "Navigating an FDA Meeting – Best Practices for Maximizing Your Time and Effort," Eric Hardter, Ph.D., RAC (US, CAN, EU) provides an in-depth exploration of two crucial aspects: Building your submission documentation and establishing a regulatory timeline. Read the blog here: https://lnkd.in/ejabPg9i or get in touch with one of our award-winning regulatory experts for personalized support in preparing for your FDA meeting, contact info@boydconsultants.com. #FDA #RegulatoryAffairs #preIND
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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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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/Q02QqCxs0 #MedicalDevices #HealthTech #MedicalSoftware #FDA #SaMD #SoftwareDevelopment #RAPSConvergence #RegulatoryCompliance
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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/Q02QqVMg0 #MedicalDevices #HealthTech #MedicalSoftware #FDA #SaMD #SoftwareDevelopment #RAPSConvergence #RegulatoryCompliance
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