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  • Regulatory NewsRegulatory News

    FDA’s CBER to Forge Stronger Ties With WHO

    The US Food and Drug Administration (FDA) on Tuesday announced it’s forging a cooperative agreement with the World Health Organization (WHO) to support further regulatory systems strengthening, development of new norms and standards and research to advance global access to safe and effective biologics that meet international standards. FDA's Center for Biologics Evaluation and Research (CBER) anticipates providing up to $2 million in FY 2016 to support the project, as w...
  • Regulatory NewsRegulatory News

    European Commission Publishes New Harmonized Standards for Devices, Implants, IVDs

    In the Official Journal of the European Union, the European Commission on Friday published a new list of the harmonized standards that manufacturers of medical devices, implantable devices and in vitro diagnostic devices can use to demonstrate their products comply with EU law. The standards were published as part of the implementation of the European Council’s Directive 93/42/EEC from 1993, which deals with medical devices and their regulation. Background ...
  • Regulatory NewsRegulatory News

    FDA Amends Regulations on General Biologic Standards for First Time Since 1977

    The revisions to US Food and Drug Administration’s (FDA) regulations, announced Tuesday, are designed to remove unnecessary or outdated biologics requirements and allow industry to employ new manufacturing technology and testing capabilities. Issued directly as a final rule – because FDA says it believes the updates include “only noncontroversial amendments” and FDA anticipates no major objections from industry – the new regulations are part of FDA’s continuing effort to...
  • Regulatory NewsRegulatory News

    Evaluating Next-Generation Sequencing: From Design Concept to Performance Standards

    Discussions are underway on how the US Food and Drug Administration (FDA) plans to develop new ways of regulating next-generation sequencing (NGS) diagnostics. Kicking off a two-day public workshop today, FDA Commissioner nominee Robert Califf said that NGS tests hold great promise for patients, but still present "tremendous uncertainty." The issue, he said, is determining "how accurate [and] how useful can we make the predictions that come from these tests." Califf als...
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    Small Regulation: FDA Adopts Three Nanotechnology Standards in Last Year

    The US Food and Drug Administration (FDA) has just adopted a new standard on the use of nanotechnology in medical devices—only its third nanotechnology standard yet adopted. Background The new standard, Surface Characterization Of Gold Nanoparticles For Nanomaterial Specific Toxicity Screening: FT-IR Method , was released on 27 January 2015 as part of a major update to FDA's List of Recognized Standards . The standards adopted by FDA are something of a deviation from...
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    FDA Will Soon Need to Publish More Information About the Outside Standards it Uses

    The US government's Office of the Federal Register (OFR) has finalized a rule calling on the federal agencies, including the US Food and Drug Administration (FDA), to offer more information about third-party standards they require companies to comply with. Background If you're in the regulated healthcare products space—and in particular are involved with medical devices —you probably already know a thing or two about standards. There are of course standards FDA creates...
  • FDA Clears Way for Generic Invokana, Xalkori, Tecfidera and Dozens of Other Drugs

    The US Food and Drug Administration (FDA) has released 37 new bioequivalence (BE) standards intended to facilitate the development of abbreviated new drug applications (ANDAs) that best meet FDA's expectations for evidence. Background Bioequivalence refers to the "absence of a significant difference" between the bioavailability—specifically the extent and rate of absorption—of two (supposed) pharmaceutical drug equivalents over the course of a period of time, at the sam...
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    Public Comment Period Opens on ISO 9001, Major Device Quality Standard

    The International Standards Organization (ISO), an international group whose standards are widely used in the life sciences industry, has finally released a draft of its latest iteration of the ISO 9001 standard for public consultation. Background The standard, which covers Quality Management Systems (QMS), undergoes  a revision process once every five years, and was last updated in 2008 (ISO 9001:2008). The ISO 9001 standard is used extensively throughout the medical...
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    FDA Releases 33 New Medical Device Standards

    US medical device regulators have announced more than 30 new additions to their list of recognized device consensus standards. In a Federal Register announcement on 9 July 2014, the US Food and Drug Administration (FDA) announced its 36th update to its "List of Recognized Standards"—its fourth update to the list in 2014—containing dozens of modifications and 33 newly recognized standards. Those standards come to be recognized by FDA through a process known as "i...
  • FDA Re-Recognizes Three Radiology Consensus Standards

    The Center for Devices and Radiological Health (CDRH), the US Food and Drug Administration's (FDA) device regulatory body, has released another update-its 35th-to its list of recognized third-party standards. Background Standards for the proper manufacture and testing of products are often highly technical, time-consuming to produce and, above all else, expensive to create. Rather than create its own standards or duplicate the efforts of other groups, FDA often chooses ...
  • FDA Guidance: How to use Voluntary Consensus Standards Properly for Device Submissions

    A new draft guidance document issued by the US Food and Drug Administration (FDA) seeks to establish a framework for the use of voluntary consensus standards in medical device premarket submissions. Background FDA regularly establishes its own standards, such as through regulation or guidance documents, which product sponsors are expected to follow. However, it also regularly looks to standards set by outside bodies of experts, and adopts those standards in a process k...
  • FDA Issues Report on Therapeutic Area Standards Development, Outlining Future Guidance

    Regulatory officials with the US Food and Drug Administration (FDA) have announced the launch of a project they're calling the Therapeutic Area Standards Initiative Project Plan (TASIPP), which aims to develop and implement new standards to aid in the regulatory review of drugs and biologics. Background FDA has long been interested in addressing common bottlenecks in the regulatory review process, believing that such work can generate industry-wide returns in productivi...