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  • Regulatory NewsRegulatory News

    Coronavirus Prompts IMDRF to Cancel 3 Meetings

    In consideration of the ongoing coronavirus (COVID-19) outbreak, the International Medical Device Regulators Forum (IMDRF) has cancelled three upcoming meetings in Singapore.   The three meetings were to be held from 16-19 March and include the IMDRF-DITTA Joint Workshop on Cybersecurity, IMDRF Stakeholder Forum and the IMDRF Management Committee Meeting.   According to the latest World Health Organization (WHO) situation report , there are now more than 71,000 co...
  • Regulatory NewsRegulatory News

    Modernizing ClinicalTrials.gov: NIH Seeks Feedback

    As part of a multi-year modernization initiative, the National Institutes of Health’s (NH) National Library of Medicine (NLM) is seeking comments from users and submitters to ClinicalTrials.gov on what can be done to improve the clinical research registry. The website is home to information on more than 300,000 clinical trials and since 2007, certain trials must be registered and information must be submitted to Clinicaltrials.gov. FDA in 2018 released draft guidance...
  • Regulatory NewsRegulatory News

    Rx-to-OTC Switches: FDA Signs Off on Three Drugs

    The US Food and Drug Administration (FDA) last Friday converted three prescription drugs to over-the-counter (OTC) drugs, increasing access to the medicines, including one for arthritis pain and two for redness of the eyes and itching due to allergies. The process of such prescription drug to OTC drug switches (known as Rx-to-OTC switches) is usually initiated by the manufacturer, FDA said. “For a drug to switch to nonprescription status, the data provided must demon...
  • ReconRecon

    Recon: BMS Reports Long Term Results for Opdivo in Kidney Cancer; Cancer Drug Shortages Hit Mexico’s Public Health System

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US DOJ’s Generic Drug Criminal Probe Snares Ex-Sandoz Exec ( Law360 -$) ( DoJ ) BMS unveils long-term results for Opdivo in kidney cancer ( PMLive ) ( Press ) ( Press ) N-of-1 drugs push biopharma frontiers ( Nature ) A city in Georgia is the latest to sue Mallinckrodt over its pricey Acthar Gel medicine ( STAT ) Solving the mystery of Vifor’s new voucher ( Vant...
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    Court Finds Sanofi Improperly Listed Insulin Device Patent in FDA’s Orange Book

    The US Court of Appeals for the First Circuit last week ruled that Sanofi improperly submitted a patent for its insulin device in the US Food and Drug Administration’s (FDA) Orange Book and could potentially be held liable for extending its monopoly. The case concerns Sanofi’s insulin glargine product Lantus, which first won FDA approval in 2000, and pulled in almost $8 billion in US sales in 2014. With its original application, Sanofi submitted a patent for listing ...
  • Regulatory NewsRegulatory News

    CBER Plots New Draft Guidance in 2020 on Genome Editing, CAR-T Therapies

    The FDA’s Center for Biologics Evaluation and Research (CBER) unveiled its 2020 guidance list on Friday, with new drafts coming on several increasingly crowded areas for drug development. Three new drafts this year will likely draw lots of comments from industry and other stakeholders. They deal with considerations for the development of Chimeric Antigen Receptor (CAR) T-cell therapies, considerations for the development of human gene therapies incorporating genome edit...
  • Regulatory NewsRegulatory News

    EMA Begins Publishing All Health Professional Communications

    The European Medicines Agency (EMA) said Friday it’s now publishing all safety communications sent directly to health professionals by marketing authorization holders (MAHs) and competent authorities on its website.   In the EU and European Economic Area, direct health care professional communications (DHPCs) are used to convey important safety information about medicines either by MAHs or competent authorities, such as the suspension or withdrawal of a medicine for sa...
  • Regulatory NewsRegulatory News

    RWE: Cost and Time Savings Entice Sponsors as Pitfalls Linger

    The New England Journal of Medicine published an article earlier this week raising questions about the use of observational real world evidence (RWE), and how part of this drive toward using nonrandomized studies to assess the effects of treatments is due to the expensive and complex way that randomized clinical trials are being conducted. The timing of the article coincides with the US Food and Drug Administration (FDA) Commissioner Stephen Hahn recently pointing t...
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    RAPS' LatestRAPS' Latest

    With EU Medical Device Regulation Deadline Looming, Regulatory Pros to Gather in Brussels for RAPS Euro Convergence

    RAPS will host its annual European conference, newly dubbed Euro Convergence 2020 , in Brussels, 11–13 May, at the Radisson Blu. The event will draw a broad range of professionals and regulators concerned with the regulation of medical devices, medicines and other healthcare products, and take place just two weeks before the planned implementation of the EU’s extensive overhaul of its rules governing devices, the Medical Device Regulation (EU MDR).   While much attent...
  • Regulatory NewsRegulatory News

    CBER Raises Concerns With Cell Product Promoter RejuvaYou

    The US FDA’s Office of Compliance and Biologics Quality in the Center for Biologics Evaluation and Research (CBER) earlier this week raised alarms with South Pasadena, CA-based RejuvaYou Medical Corporation, which claims to treat people with serious illnesses with umbilical cord blood and other cellular products. RejuvaYou markets the products to treat various diseases or conditions, including some that are serious or life-threatening, FDA’s untitled letter notes, and t...
  • ReconRecon

    Recon: 21 States Reject Drug Wholesalers’ $18B Opioid Settlement; China NMPA Approves Roche’s Tecentriq for Lung Cancer

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US 21 States Reject $18 Billion Offer From Drug Wholesalers to Settle Opioid Litigation ( WSJ ) ( Reuters ) Americans with employer coverage saw growth in drug spending outpace other medical costs ( STAT ) As opioid crisis intensified, many family doctors found promotional pitches were very good ( STAT ) The list of the 11 blockbusters-to-be in line for a 2020 la...
  • Regulatory NewsRegulatory News

    UK Introduces Medicines, Medical Devices Bill in Post-Brexit Overhaul

    Just two weeks after Brexit, the UK government has introduced a bill to update its regulatory framework for human and veterinary medicines, clinical trials and medical devices, while ensuring the UK remains an attractive market for the life sciences industry.   The bill was read for the first time in the House of Commons on Thursday and is scheduled for a second reading on 2 March.   The UK is currently in the midst of an 11-month transition period ending 31 Decemb...