FDA’s Post

Valuable and well awaited guidance for accelerated developments

Wow! Is FDA actually needing to have a guidance document to define weather a trial is underway or not??? You gotta be freaking kidding me! Does the industry really need a guidance document for same??? Sounds more like a bunch of nothing created by a gaggle of zoom meeting, teleworking sand overpaid Commission Corp./FDA employees attempting to justify their existence. Go back to the office become accountable and go back to conducting meaningful inspections. If you can’t figure out if a “trial” actually going on or not, McDonalds I hiring.

The Accelerated Approval pathway has become more stringent, and Sponsors need to ensure they are preparing early and communicating effectively with all stakeholders, particularly FDA, about the clinical meaningfulness of the treatment *and* plans for a confirmatory trial. By the End-of-Phase 2 meeting with the Agency, the Applicant should ensure agreement on study design, so that by the time AA is granted, the trial is truly "underway" and benchmarks/readout will be met. See below for draft guidance. Comments are due by March 10, 2025! #regulatory #drugapproval #communications #fda #confirmatorytrial

FDA issued a draft guidance, Accelerated Approval and Considerations for Determining Whether a Confirmatory Trial is Underway. This draft guidance, when finalized, will describe FDA’s interpretation of the term “underway” and policies for implementing this requirement, including factors FDA intends to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. Check out the guidance or read it below: https://lnkd.in/gZwVzyfT

New draft guidance on Accelerated Approval: FDA's interpretation of the term "underway" with respect to confirmatory trials prior to an accelerated approval.

Nothing about accelerated approvals is ever simple, but sponsors should take some comfort in how the US FDA is codifying the general withdrawal procedures. Sue Sutter's story, part of a series analyzing the agency's recent guidance, is now outside the Pink Sheet paywall, courtesy of Citeline Regulatory. https://lnkd.in/e3gmEixY

‼️ Also: FDA just published its comprehensive report/summary from the public clinical trial diversity workshops it held last Fall. This satisfies a FDORA requirement. Can't wait to dive in and review the key take-aways and conclusions 🤓 Check it out here: https://lnkd.in/eW3WYyCW #HealthEquity #ClinicalTrialDiversity #InclusiveResearch

View all Official FDA Guidance Documents and other Regulatory Guidance: You can search for documents using key words, and you can narrow or filter your results by product, date issued, FDA organizational unit, type of document, subject, draft or final status, and comment period: https://lnkd.in/eAfW-r53

A long-awaited draft guidance on accelerated approval unveiled last week by the FDA offers some new details about the agency’s “expedited” withdrawal process that is anything but fast. For sponsors who were hoping to learn new details about what the agency wants to see as part of confirmatory studies initiated prior to approval, the agency’s guidance has a simple message: Please wait for further guidance. AgencyIQ Alexander Gaffney, MS, RAC Amanda Conti

✏ 📝 US FDA Reorganizes Medical Device Guidance Databases The US FDA has implemented changes to enhance the accessibility of regulatory guidance for specific medical device types. Now, FDA guidance documents are categorized into Class II Special Controls Documents for specific device types and other guidance documents. This reorganization aims to streamline the search process for companies seeking guidance on device-specific regulations. Explore the updated FDA guidance databases here: [Link to FDA Guidance Documents](https://lnkd.in/e4pTUuCt) Do you believe this update will simplify the process of finding device-specific guidance for companies in the medical device industry? #FDA #Medicaldevices