Joshua Fedewa’s Post

sIRB mandate from FDA is on the horizon. Are you ready? Join us for an exclusive webinar on developing a robust sIRB action plan to streamline your research processes. Learn valuable insights from industry experts - Joshua Fedewa and Adam J McClintock and enhance your compliance strategies. #ResearchCompliance #Webinar #Advarra #sIRB #FDA #clinicalresearch #clinicaltrials #trials

Kudos to the FDA for drafting a new guidance regarding informed consent which encourages trial sponsors to simplify the wording and shorten the ICF. Many ICFs read like legal documents nowadays. This completely mises the point of an ICF which is to provide information regarding clinical trial participation in simple, clear, and concise terms. #clinicaltrials #patientsfirst #informedconsent #FDA https://lnkd.in/eu_7dfT6

📅 As the critical June 22, 2024, deadline approaches, it's essential for Annex XVI manufacturers to stay informed about the transitional provisions.   🔍 To help you navigate these complex regulations, we've developed a comprehensive flowchart.    🛠️ Key Deadline Alert for manufacturers intending to perform a clinical trial: by June 22, 2024, sponsors should receive confirmation from the EU Member State regarding their clinical trial authorization request to continue placing their products on the EU market    For more detailed information on the deadlines and requirements, visit: MDlaw: https://lnkd.in/eiNUEi48   Stay compliant and ensure your products meet the new regulatory standards!   #MedicalDevices #AnnexXVI #RegulatoryCompliance #ClinicalTrials #MDR #ObelisGroup #MDlaw

Recently, the FDA completed one of its largest transformations, impacting almost every part of the agency. This installment of FDA In Your Day highlights two of the many examples of the important work the FDA is doing every day to keep us safe!

🚨🇺🇸Exciting changes at the #FDA! A complete #transformation and #reorganization are underway. Here are two key highlights showing how these shifts are benefiting US citizens. Did you know that about every 30 minutes an inspection is being initiated? Watch the video to learn more!🍀🚨

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

💡 Overview of FDA Guidance Documents published in early 2024 💡 ❓ In the dynamic landscape of medical device regulation, clarity and efficiency are paramount for both industry stakeholders and regulatory agencies. Recently, the Food and Drug Administration (FDA) has released several draft guidance documents aimed at providing clarity on various aspects of premarket submissions and regulatory assessments. These guidance documents serve to update existing recommendations, clarify requirements, and streamline processes, ultimately enhancing the quality and efficiency of FDA submissions. 📢 📖 Some FDA guidance have recently been published. Below is a summary of documents published since January 2024. All FDA guidance are available here 👉 https://lnkd.in/eCZaPGy 👉 𝑺𝒖𝒃𝒎𝒊𝒔𝒔𝒊𝒐𝒏 𝒂𝒏𝒅 𝑹𝒆𝒗𝒊𝒆𝒘 𝒐𝒇 𝑺𝒕𝒆𝒓𝒊𝒍𝒊𝒕𝒚 𝑰𝒏𝒇𝒐𝒓𝒎𝒂𝒕𝒊𝒐𝒏 𝒊𝒏 𝑷𝒓𝒆𝒎𝒂𝒓𝒌𝒆𝒕 𝑵𝒐𝒕𝒊𝒇𝒊𝒄𝒂𝒕𝒊𝒐𝒏 (510(𝒌)) 𝑺𝒖𝒃𝒎𝒊𝒔𝒔𝒊𝒐𝒏𝒔 𝒇𝒐𝒓 𝑫𝒆𝒗𝒊𝒄𝒆𝒔 𝑳𝒂𝒃𝒆𝒍𝒆𝒅 𝒂𝒔 𝑺𝒕𝒆𝒓𝒊𝒍𝒆. https://lnkd.in/eErnp6fU 👉 𝑪𝒉𝒂𝒓𝒂𝒄𝒕𝒆𝒓𝒊𝒛𝒂𝒕𝒊𝒐𝒏 𝒐𝒇 𝑴𝒆𝒕𝒂𝒍𝒍𝒊𝒄 𝑪𝒐𝒂𝒕𝒊𝒏𝒈𝒔 𝒂𝒏𝒅/𝒐𝒓 𝑪𝒂𝒍𝒄𝒊𝒖𝒎 𝑷𝒉𝒐𝒔𝒑𝒉𝒂𝒕𝒆 𝑪𝒐𝒂𝒕𝒊𝒏𝒈𝒔 𝒐𝒏 𝑶𝒓𝒕𝒉𝒐𝒑𝒆𝒅𝒊𝒄 𝑫𝒆𝒗𝒊𝒄𝒆𝒔. https://lnkd.in/eVb77_gT 👉 𝑪𝒐𝒏𝒅𝒖𝒄𝒕𝒊𝒏𝒈 𝑹𝒆𝒎𝒐𝒕𝒆 𝑹𝒆𝒈𝒖𝒍𝒂𝒕𝒐𝒓𝒚 𝑨𝒔𝒔𝒆𝒔𝒔𝒎𝒆𝒏𝒕𝒔 𝑸𝒖𝒆𝒔𝒕𝒊𝒐𝒏𝒔 𝒂𝒏𝒅 𝑨𝒏𝒔𝒘𝒆𝒓𝒔: 𝑫𝒓𝒂𝒇𝒕 𝑮𝒖𝒊𝒅𝒂𝒏𝒄𝒆 𝒇𝒐𝒓 𝑰𝒏𝒅𝒖𝒔𝒕𝒓𝒚. https://lnkd.in/g4M_Y6xM 👉 𝑺𝒆𝒍𝒆𝒄𝒕 𝑼𝒑𝒅𝒂𝒕𝒆𝒔 𝒇𝒐𝒓 𝒕𝒉𝒆 𝑴𝒆𝒅𝒊𝒄𝒂𝒍 𝑫𝒆𝒗𝒊𝒄𝒆 𝑼𝒔𝒆𝒓 𝑭𝒆𝒆 𝑺𝒎𝒂𝒍𝒍 𝑩𝒖𝒔𝒊𝒏𝒆𝒔𝒔 𝑸𝒖𝒂𝒍𝒊𝒇𝒊𝒄𝒂𝒕𝒊𝒐𝒏 𝒂𝒏𝒅 𝑪𝒆𝒓𝒕𝒊𝒇𝒊𝒄𝒂𝒕𝒊𝒐𝒏 𝑮𝒖𝒊𝒅𝒂𝒏𝒄𝒆. https://lnkd.in/eNsPPfkP   🖋 In conclusion, these recent draft guidance documents underscore the FDA's commitment to fostering clarity, consistency, and efficiency in the regulatory landscape. By providing updated recommendations and clarifications, these guidance documents empower industry stakeholders to navigate regulatory processes effectively while ensuring the safety and efficacy of medical devices for the benefit of patients worldwide. 🔶 To keep in touch with all the latest regulatory news, subscribe to our page EXPEREG or follow our consultants : Franck Martin / Juliette Desvilles / David HOUOT🔶 #FDA #medicaldevice #guidance #regulatoryaffairs #quality

How do you navigate compliance complexities of hosting and preparing your sites for an FDA inspection? Join industry experts Stuart Cotter and Leslie Paul tomorrow, February 29th, at 1pm ET to hear the latest on strategies for sponsors and sites to be inspection ready! #GCP #ClinicalTrials #FDAInspection

The only constant is change – especially in regulations. The FDA's proposed sIRB mandate signifies a dramatic shift in power from sites to sponsors, which is guaranteed to have a seismic impact on our industry. Advarra's James Riddle shares three important steps forward for sponsors & CROs in navigating this change. 👇 Full article by James here: https://lnkd.in/gUQTngKK #ClinicalResearch #ClinicalTrials

🔍 Curious about the new FDA LDT Final Rule? 🧪 Shannon Bennett, MS, MBA, breaks down the key terminology every clinical lab professional needs to know to stay ahead. From compliance requirements to industry impacts, this article will help you navigate the changes confidently. Read the full article here 👉 https://bit.ly/3TD0gqu #ClinicalLab #FDA #LDT #LaboratoryCompliance #LabProfessionals