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You need to enable JavaScript to run this app. RAPS.org needs your explicit consent to store browser cookies. If you don't allow cookies, you may not be able to use certain features of the web site such as personalized content. Please see our Privacy Policy for more information. Skip to Main NavigationSkip to Main ContentSkip to Footer Close Search Search: Close Login Welcome to our new website! If this is the first time you are logging in on the new site, you will need to reset your password. Please contact us at raps@raps.org if you need assistance. 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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 » This Week at FDA: New guidance, a new super office, and farewell to Janet Woodcock FEATURED BOOKS » Essentials of Healthcare Product Labeling, Second Edition POPULAR EVENTS » 2024 Combination Products in the EU, presented by DIA and RAPS FEATURED LEARNING » 2023 NMPA (CFDA) Key Updates and Look Ahead on 2024 (On Demand) 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. Learn More RAPS EURO CONVERGENCE 2024 REGISTRATION AND HOUSING ARE NOW OPEN. JOIN RAPS TODAY JOIN RAPS RAPS MEMBERSHIP PROVIDES THE RESOURCES YOU NEED TO ADVANCE YOUR REGULATORY CAREER. FIND YOUR NEXT JOB JOB POSTINGS VISIT RAPS CAREER CONNECTIONS FOR THE LATEST JOB POSTINGS IN REGULATORY AFFAIRS. 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. JOIN RAPS TODAY JOIN RAPS RAPS MEMBERSHIP PROVIDES THE RESOURCES YOU NEED TO ADVANCE YOUR REGULATORY CAREER. FIND YOUR NEXT JOB JOB POSTINGS VISIT RAPS CAREER CONNECTIONS FOR THE LATEST JOB POSTINGS IN REGULATORY AFFAIRS. 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 26 JAN 2024 | BY LINDSEY TRAN, PHARMD FDA GUIDANCE ON QUANTITATIVE INFORMATION IN DTC ADVERTISING: IMPLICATIONS FOR SOCIAL MEDIA The US Food and Drug Administration (FDA) oversees the advertising and promotion of prescription drug products under the Federal Food, Drug, and Cosmetic Act (FDCA). Companies can market their... 26 JAN 2024 | BY OLIVIA WALKER, PHARMD SHARING SCIENTIFIC INFORMATION ON UNAPPROVED USES: AN FDA GUIDANCE UPDATE In October 2023, the FDA published a new draft guidance detailing how companies can share communications with healthcare providers regarding scientific information on unapproved uses (SIUU) of... 26 JAN 2024 | BY YURI CERAGIOLI, MS IMPURITIES MANAGEMENT IN DRUG SUBSTANCES: A SIMULATED CASE STUDY This article is the third in a series focused on regulatory management of impurities, introducing the topic of impurities in both drug substances and drug products from a regulatory CMC perspe... 26 JAN 2024 | BY RYAN CONNORS MEDCON 2024 TO CONVENE APRIL 24-26 IN COLUMBUS, OHIO The AFDO/RAPS Healthcare Products Collaborative has opened registration for the MedCon 2024 Conference . Main conference sessions will be held at the Hilton Columbus Downtown in Columbus, Ohi... REGULATORY EXCHANGE » By Christoph Kiesselbach 29 January 2024 7:23 am Regulatory Open Forum RE: CE design certificate Thanks Kevin for reaching out to DQS, and please note the edit of my previous post: DQS seems to have been consistent and just have clarified the des... By Naveen Agarwal 29 January 2024 6:47 am RAPS Career Community RE: Career Transition from Product Development/ Tech Transfers into Regulatory Affairs & Looking for new opportunities Hello Sowmya First, I want to congratulate you for considering this career move. I think your product development and tech transfer background will... By Anonymous Member 29 January 2024 2:54 am Regulatory Open Forum RE: IND/IMPD - For an adaptive Clinical trials (single phase 2&3 study) This message was posted by a user wishing to remain anonymous Yes you can request EOPII meeting with the FDA and get feedback on your adaptive regis... By Olga Peycheva 29 January 2024 2:42 am Regulatory Open Forum RE: IND/IMPD - For an adaptive Clinical trials (single phase 2&3 study) Hello Maddigunta, I have experience with Europe so I will comment about that and leave my colleagues to explain about FDA. a) It depends on th... By Marisa Testa 28 January 2024 11:13 pm Italy Local Networking Group Teams meeting volontari 30 gennaio h13 Ciao a tutti, ricordo il meeting virtuale per i volontari dell'Italy LNG pianificato per domani 30 gennaio 2024 alle ore 13. I candidati che non av... 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