Regulatory Affairs Professionals Society (RAPS)’s Post

Check out our Q1 newsletter for an important notice from the FDA, AAOS highlights, and the Employee Spotlight on our Quality Supervisor, Michelle Yepes Mejia. Stay informed and ahead of the game with our quarterly roundup! #Q1Newsletter #Updates #FDA #AAOS2024 #EmployeeSpotlight

A “Cliff’s Notes” version, to go with many other notes about how to implement ISO 13585 plus for LDTs.

Among FDA-regulated establishments and stakeholders, there is one word that makes everyone go on edge – the dreaded FDA "inspection." ✔ In an effort to clarify for industry and alleviate some of the stress associated with these activities, last week the FDA issued a draft guidance aimed at providing recommendations on how to handle inspections under FDA's Bioresearch Monitoring (BIMO) program. ✔ This draft guidance, titled "Processes and Practices Applicable to Bioresearch Monitoring Inspections," was prompted by a congressional directive under the Food and Drug Omnibus Reform Act and is intended to provide recommendations that are not otherwise specified in existing publicly available guides and manuals for such inspections (see pages 11-12 of the guidance for a list of these resources). ➡ It is critical that this guidance be reviewed in tandem with the guidance set forth in FDA's Investigations Operations Manual (IOM) and the Regulatory Procedures Manual (RPM), both of which provide more detail about how FDA investigators conduct investigations and make decisions about a firm's regulatory compliance. 💡 Comments on the draft guidance can be submitted to the docket by 5 August 2024. #FDA #BIMO #FDAInvestigation ~#FDAInspections

FDA Draft Guidance Updates Definitions and Standards for Postapproval Safety Data: The FDA has adopted an updated guidance from the International Council on Harmonisation (ICH) that provides clarification on how to factor in new and increasingly used data sources, such as social media or patient support programs, when reporting individual case safety reports postapproval. #fda #financial #lifesciences

Did you miss our executive roundtable webinar earlier today on 'Navigating the FDA's Laboratory Developed Tests Regulation?' Good news. - The recording and slides will be emailed to everyone who registered! - The presentation will be available on demand via our website - We are still taking questions! Just a few hours ahead of our discussion, the Office of Information and Regulatory Affairs (OIRA) updated their status 'Final Rule' with a concluded date of April 22, 2024; so we are anticipating this to be published any day now. Should we do a part two after it's published? If so, anyone else we should invite to the conversation? Link to the on demand resources + OIRA update in the comments. #Diagnostics #LabDevelopedTests #FDA

Last week the FDA issued new draft guidance for the #QSubmission. The revised guidance provides clearer information for manufacturers to determine when an informal communication is more appropriate than a full Q-Submission, gives further detail on Q-Submission types and also provides more details on #PMA Day-100 Meetings. Comments are open until 15 April 2024. Q-Subs are one of the most useful tools for an FDA submission, if used correctly. Our top tip is to have targeted questions prepared. https://lnkd.in/gJEa6RTp

LDTs, In house in vitro diagnostics under FDA..not only under the IVDR a new field!!! nice and clear article from Regulatory Affairs Professionals Society (RAPS) for better understanding!!

Bottom line. If you are not including CODefs in your protocol and study report you’ll get asked for them. Contact myself and the team at Navidence to help you embed these in your RWE Design and RWD Assessment.

The TMA panel "Common Goals: Improving Product Pathways & Regulations" sparked an open, insightful, and engaging dialogue on the pathways to market for nicotine products. Key positive takeaways: 1. The FDA CTP is considering how they can improve their processes. 2. The Office of Science should continue producing excellent research to provide direction. 3. The Substantial Equivalence (SE) pathway is working efficiently – it's easy, fast, and cost-effective. 4. There has been an uptick in enforcement, demonstrating the FDA's commitment to regulation. 5. The website on relative risk is a positive step towards educating the public. While progress is being made, there is still room for improvement. Closing panelist suggestions to the FDA CTP: 1. Trust your scientists – their expertise is invaluable. 2. Improve timelines to streamline the process. 3. Reprioritize to focus on the most critical aspects of regulation. By implementing these changes, we can work towards a more efficient and effective regulatory landscape for nicotine products. What are your thoughts on the current state of nicotine product regulation? Share your insights in the comments below! #TMA #NicotineRegulation #ProductPathways #FDAImprovement

Join Louise Uí Fhatharta for our upcoming webinar on "Preparing for a Successful Inspection". Gain insights into best practices for preparing your organization for regulatory inspections and ensuring compliance. 📅 Date: May 16, 2024 🕒 Time: 3pm GMT In this session, you'll learn: ✅ Proactive approaches to inspections ✅ Identifying key elements of regulatory noncompliance ✅ Post-inspection activities and best practices Successful health authority inspections require preparation and communication. Learn how to navigate regulatory audits effectively and set your site up for success. Register now: 🔗 https://shorturl.at/bqBDH #Pharma #InspectionReadiness #RegulatoryCompliance