• Regulatory NewsRegulatory News

    FDA Guidance Outlines Principles for Adaptive Design in Device Clinical Trials

    Content provided by Emergo , a medical device regulatory affairs and quality assurance consulting firm with offices worldwide. New draft guidance from the US Food and Drug Administration (FDA) lays out appropriate uses of medical device clinical trial designs that allow for planned trial changes to be implemented based on accrued data while maintaining study validity and integrity. Known as  adaptive design , the method can minimize clinical trial sponsors’ resou...
  • Regulatory NewsRegulatory News

    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...
  • Regulatory NewsRegulatory News

    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...
  • Regulatory NewsRegulatory News

    FDA Tries to Improve Safety, Reliability of Home-Use Devices With New Guidance

    The US Food and Drug Administration (FDA) has finalized a draft guidance intended to clarify how manufacturers should design and develop medical devices primarily used by a patient in their own home—so-called "home use" devices. Background FDA released the draft version of the guidance in December 2012 as part of its 2010 " Home Use Initiative ." As explained by FDA, the initiative is intended to "support the safe use of medical devices in the home." For example...
  • 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...
  • Regulatory NewsRegulatory News

    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...
  • Regulatory NewsRegulatory News

    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...
  • US, EU Regulators Extend QbD Pilot, Pledge Release of Further Quality Guidelines

    • 06 March 2014
    The US Food and Drug Administration (FDA) and European Medicines Agency (EMA) have extended for another two years a pilot program that allows both agencies to simultaneously review quality-by-design (QbD) applications. Background The pilot program was first launched in March 2011 as a means by which both agencies could communicate review findings with respect to QbD elements of applications chosen for review. QbD refers to purposeful pharmaceutical development in which...
  • EMA Continues to Seek Guideline on Similarity Criteria for Biosimilars

    The European Medicines Agency (EMA) has formally issued a call for a reflection paper on methods to compare quality attributes in drug development, saying that regulators need to settle on established criteria for determining acceptable ranges of "similarity criteria" in biosimilar products. Background The draft of the concept paper was released in May 2013, and explained that EMA has received several requests in recent years regarding the adequacy of data ...
  • EMA, FDA Publish New Guidance on Adhering to Quality by Design Principles

    European regulators have announced that they, along with the US Food and Drug Administration (FDA), have released a second question-and-answer document intended to provide guidance to industry on the concept of "quality by design," or QbD. Background The QbD concept is well-known within most regulatory circles. Simply stated, it is the belief that quality should be designed-not tested-into the final product, including its manufacturing processes. In theory (and regulato...