True North Contract Research’s Post

FDA Issues Draft Guidance on Accelerated Approval: A Substantial Evidentiary and Procedural Overhaul to this High-Profile Pathway ''FDA’s new accelerated approval guidance is a must read. The discussion provides a wide-ranging and much needed update on FDA policies and interpretation of its accelerated approval authorities.'' Link to full article in the comments below

🎤 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

🎤 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

🎤 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

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

The FDA has released a draft guidance titled "Accelerated Approval and Considerations for Determining Whether a Confirmatory Trial is Underway."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

The FDA has issued a draft guidance document entitled Accelerated Approval and Considerations for Determining Whether a Confirmatory Trial is Underway. This draft guidance, when finalized, will describe FDA’s interpretation of the term “underway” and policies for implementing this requirement, including factors FDA intends to consider when determining whether a confirmatory trial is underway prior to an accelerated approval action. - To discuss this update and for expert regulatory guidance, speak to a member of the team today www.scendea.com/contact - #FDA #regulatoryaffairs #drugdevelopment

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

New blog section is available! Link below.

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