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GO MY RAPS » DISCOVER MORE OF WHAT MATTERS TO YOU Advanced therapies/cell and gene therapyAPIsBiologics/ biosimilars/ vaccinesBiotechnologyCombination products/companion diagnosticsCosmeticsDiagnostics/IVDsDigital health/SaMD/AIGenericsMedical DevicesNutritional/Natural HealthOTCOtherPharmaceuticals TRENDING NEWS » What 2 former FDA officemates wish you knew about radiological health regulation FEATURED BOOKS » Essentials of Healthcare Product Labeling, Second Edition POPULAR EVENTS » RAPS France LNG Virtual Event: Future IA act in Europe : Quality Management System and Risk management impacts of this satellite regulation to MDR and IVDR FEATURED LEARNING » Comprehensive CAPA RAPS HIGHLIGHTS Read today RF QUARTERLY READ THE NEW ISSUE OF RAPS' MEMBER-EXCLUSIVE DIGITAL PUBLICATION. Get your copy YOUR GUIDE TO LABELING WITH REFRESHED CONTENT FROM INDUSTRY EXPERTS Download Now SEE HOW YOU MEASURE UP WITH THE MOST COMPREHENSIVE RESEARCH INITIATIVE ON THE GLOBAL REGULATORY PROFESSION. 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FIND YOUR NEXT JOB JOB POSTINGS VISIT RAPS CAREER CONNECTIONS FOR THE LATEST JOB POSTINGS IN REGULATORY AFFAIRS. Join us in Brussels RAPS AND DIA EXPLORE A COORDINATED DRUG AND DEVICE APPROACH TO INCENTIVISE COMPETITIVE INNOVATION IN EUROPE. Read today RF QUARTERLY READ THE NEW ISSUE OF RAPS' MEMBER-EXCLUSIVE DIGITAL PUBLICATION. Get your copy YOUR GUIDE TO LABELING WITH REFRESHED CONTENT FROM INDUSTRY EXPERTS Download Now SEE HOW YOU MEASURE UP WITH THE MOST COMPREHENSIVE RESEARCH INITIATIVE ON THE GLOBAL REGULATORY PROFESSION. Learn More RAPS EURO CONVERGENCE 2024 REGISTRATION AND HOUSING ARE NOW OPEN. * 1 * 2 REGULATORY FOCUS » Subscribe 17 JAN 2024 | BY JOANNE S. EGLOVITCH CDER’S OFFICE OF COMPLIANCE HIGHLIGHTS ENFORCEMENT ACTIONS IN 2023 The Office of Compliance (OC) in the US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) said preventing diethylene glycol (DEG) or ethylene glycol (EG) cont... 16 JAN 2024 | BY FERDOUS AL-FARUQUE EMA RECOMMENDED 77 DRUGS, REJECTED 3 IN 2023 The European Medicines Agency (EMA) said it recommended 77 drugs for marketing authorization in the European Union last year and recommended against the authorization of three drugs, according... 16 JAN 2024 | BY JOANNE S. EGLOVITCH WARNING LETTERS: SAME OLD, SAME OLD AT FDA Four warning letters posted earlier this year highlight that everything old is new again when it comes to enforcement problems for the US Food and Drug Administration.   16 JAN 2024 | BY JASON SCOTT RECON: ALLAKOS CUTS ITS WORKFORCE BY 50%, HALTS LEAD INFLAMMATORY CANDIDATE; TAKEDA WINS ANOTHER FDA APPROVAL FOR IMMUNE GLOBULIN THERAPY HYQVIA Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing. REGULATORY EXCHANGE » By Jonathan Amaya-Hodges 18 January 2024 2:39 pm Regulatory Open Forum RE: Our Ask Me Anything with Ludger Möller starts now! Amanda, I concur with Ludger's response to consult a statistician. Although I am not a statistician myself (but have enough statistical training to b... By Naveen Agarwal 18 January 2024 2:35 pm Regulatory Open Forum How is AI/ML changing the nature of work in QA/RA? Dear colleagues, hello! 👋 It is now clear that rapid advancement in AI/ML is transforming life around us, including the nature of work in QA/RA sp... By Richard Vincins 18 January 2024 12:50 pm Regulatory Open Forum RE: Switch from AIMDD Production to MDR Production Hello Britta, Sydney provided the excellent information specific to the point. I just wanted to provide a comment which hopefully is already being... By Richard Vincins 18 January 2024 12:43 pm Regulatory Open Forum RE: Frequency of LAL Testing Thomas, Going back years and years, this came out of issues with devices resulting in people getting sick or infections in the wounds or surgical p... By Erik Vollebregt 18 January 2024 9:34 am Regulatory Open Forum RE: Basic UDI-DI & UDI-DI Always make sure to dare to be wise and understand the system (which includes not only issuing entity rules about how a GTIN can be composed but also... 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