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  • Regulatory NewsRegulatory News

    FDA Unveils Six-Part Toxicology Roadmap to Expand Predictive Capabilities

    The US Food and Drug Administration’s (FDA) Toxicology Working Group this week laid out a six-part roadmap to help the agency better evaluate new methodologies and technologies for their potential to expand FDA’s toxicology predictive capabilities and to potentially reduce the use of animal testing. "Acceptance of any new toxicology methods will require sufficient convincing data as well as continuous dialogue and feedback among all relevant stakeholders from deve...
  • Feature ArticlesFeature Articles

    The Medical Device Coordination Group: a new Authority Under EU Device Regulations

    This article discusses the organization and functions of the Medical Device Coordination Group (MDCG) established under the new EU Medical Device Regulation (MDR) and In Vitro Diagnostic Medical Device Regulation (IVDR). The article explains how both groups will be important players in the conformity assessment body 'notification' process and in determining how notified bodies assess and certify devices and in serving as a reviewing body for making regulatory and jurisdi...
  • Regulatory NewsRegulatory News

    Small Biopharma Face Distinct Challenges: FDA Official and Sanofi Genzyme SVP Argue

    Small biopharmaceutical companies, often known as the drivers of innovation, face a number of unique challenges in bringing new treatments, particularly for rare diseases, to market, Richard Moscicki, deputy director for science operations at the US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research, and P.K. Tandon, senior vice president of Sanofi Genzyme, wrote. In an article published Tuesday in the New England Journal of Medicine , the a...
  • Feature ArticlesFeature Articles

    Drug Development in Asia: Scattering the Mist

    This article discusses misconceptions and their causes, surrounding drug development in Asia, and explains the regions current drug development landscape. Introduction Asia is a huge landmass with contrasting physical and human geographies. The economic panorama within this rich milieu of human geography has become one of Asia's most prominent features, and many major pharmaceutical companies are acquainting themselves with the unique regulatory and medical landscape ...
  • Regulatory NewsRegulatory News

    FDA Warns Heater Cooler Maker Over Cleaning Instructions

    The US Food and Drug Administration (FDA) issued a warning letter to medical device maker LivaNova (formerly Sorin Group) for inadequately validating and verifying certain processes intended to clean and disinfect the company's Heater Cooler 3T devices. Because of the violations FDA says it is "taking steps to refuse entry" of devices made at LivaNova's Munich facility until the company addresses the violations. The agency also says that some of the changes in recent ver...
  • Regulatory NewsRegulatory News

    ANVISA Extends Deadline for Technical Requirement Responses in Brazil

    Content provided by Emergo , a medical device regulatory affairs and quality assurance consulting firm with offices worldwide. Brazilian medical device market regulator ANVISA has officially extended deadlines for market applicants to respond to technical inquiries regarding their registration submissions. ANVISA’s technical requirement response deadline, previously 90 days, has been extended to 120 days from confirmation of requirement receipt by applicants. The...
  • Regulatory NewsRegulatory News

    US FDA Proposes Changes to MedWatch Program for Healthcare Products

    Content provided by Emergo , a medical device regulatory affairs and quality assurance consulting firm with offices worldwide. US drug and medical device market regulators are proposing changes to voluntary and mandatory post-market reporting forms used by consumers and healthcare providers for adverse events related to medical products. The Food and Drug Administration is seeking comment through July 1, 2015 on  changes  to three reporting components of its MedW...
  • Regulatory NewsRegulatory News

    Hong Kong Regulators Launch Voluntary Distributor Registration System

    Content provided by Emergo , a medical device regulatory affairs and quality assurance consulting firm with offices worldwide. Hong Kong’s Medical Device Control Office (MDCO), the region’s medical device market regulator, has set up a  voluntary listing and registration  option for device distributors. Distributors who apply for listing and registration will be searchable under the Medical Device Administrative Control System, the MDCO’s online portal that also ...
  • Regulatory NewsRegulatory News

    FDA Identifies More Than 20 PMA Devices Eligible for Reclassification to Class II

    Content provided by Emergo , a medical device regulatory affairs and quality assurance consulting firm with offices worldwide. The US Food and Drug Administration’s Center for Devices and Radiological Health (CDRH) has identified 21 medical device product codes as candidates for reclassification from Class III to Class II as part of a broad review of pre- and post-market data collection processes. Balancing pre- and post-market data collection is one of the FDA...
  • Regulatory NewsRegulatory News

    Major Changes Set for Taiwan’s Medical Device Registration Process

    Content provided by Emergo , a medical device regulatory affairs and quality assurance consulting firm with offices worldwide. The Taiwan Food and Drug Administration (TFDA) plans to implement significant changes to its registration and approval system for medical devices, according to Emergo consultants in Taipei. The regulatory changes will take effect starting 1 July 2015.  First, TFDA will introduce a two-step review program for marketing authorization appli...
  • Regulatory NewsRegulatory News

    FDA Approving Most New Drugs and Biologics During Their First Review, Report Finds

    The US Food and Drug Administration's (FDA) is now approving more new drugs and biologics during their first review cycles than at any time since at least 2008, a new FDA-commissioned report shows. Background The report , conducted by the Eastern Research Group (ERG) on behalf of FDA, is focused on the fifth iteration of the Prescription Drug User Fee Act (PDUFA) , which was passed in 2012 under the Food and Drug Administration Safety and Innovation Act (FDASIA) . P...
  • Regulatory NewsRegulatory News

    Health Canada to Stop Accepting Hard Copies of Class III, IV MDL Application and Fee Forms

    Content provided by Emergo , a medical device regulatory affairs and quality assurance consulting firm with offices worldwide. Canadian medical device market regulator Health Canada will stop accepting hard copies of some Medical Device License (MDL) application forms starting 1 April 2015, and will also require a separate fee form to be electronically submitted with application forms starting on that same date. According to an email notice sent out 18 March by H...