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  • Regulatory NewsRegulatory News

    FDA Seeks Input on Analysis Data Reviewer's Guide for Drug Submissions

    The US Food and Drug Administration (FDA) on Tuesday opened for public consultation a proposed analysis data reviewer's guide (ADRG) template developed as part of a collaboration with the Pharmaceutical Users Software Exchange (PhUSE). FDA says it is seeking comments from stakeholders to inform its review of the proposed template to determine whether the agency will recommend the template as is, or with modifications, for regulatory submissions involving study data. Acc...
  • Regulatory NewsRegulatory News

    FDA Warns of Complications With Neurovascular Catheters

    The US Food and Drug Administration (FDA) on Wednesday warned healthcare providers of potential harm to patients when neurovascular guide catheters are used to remove blood clots in stroke patients. "FDA was originally made aware of the issue based on information received from a complaint alleging regulatory misconduct, which made the agency aware that marketing materials from multiple companies imply a new intended use for some neurovascular guide catheters for neurovas...
  • EMA Tries to Clamp Down on Revolving Door of Regulators

    EU regulators have released a new "best practices" guide intended to steer the European Medicines Agency (EMA) clear of the types of perceived conflicts of interest that plagued the agency's former leader. Background In 2012, EMA was publicly chided by the European Court of Auditors (ECA), which said it had inadequately managed situations involving conflict of interest (COI). While those COIs spanned a wide number of areas, among the most critical identified was the ...
  • DOJ Officials Release 'Unprecedented' Guide on Anti-Corruption Law

    It can be difficult for companies-especially ones whose products are sold around the world, as many healthcare products are-to ensure every one of their employees are acting ethically and in accordance to the law. US Department of Justice (DOJ) officials would like to make it a bit easier for those companies to comply with at least one anti-bribery law: the Foreign Corrupt Practices Act . The legislation, originally passed in the 1970s after congressional investigators ...
  • MHRA Consolidates Clinical Practice Guidelines, Regulations in New Guide

    The UK's Medicines and Healthcare products Regulatory Agency (MHRA) has released a new guide on Good Clinical Practices (GCPs) for regulatory professionals, calling it the "authoritative guide" for understanding the legislative and regulatory framework surrounding GCPs. MHRA's Good Clinical Practice Guide , released 24 September 2012, is the result of UK regulators receiving frequent feedback that its GCP framework was too disparate and was in need of a single docum...
  • FDA: Blood Products Policy Guide 'Obsolete'

    The US Food and Drug Administration (FDA) has withdrawn its compliance policy guide (CPG) governing the registration of blood banks and other companies  that prepare human blood and blood products-the third such withdrawal made this week. In a Federal Register notice posted late on 26 June, FDA said it believes its 1974 CPG, Registration of Blood Banks, Other Firms Collecting, Manufacturing, Preparing or Processing Human Blood or Blood Products (CPG 7134.01) , ...
  • Industry Comments Indicate Displeasure with Medication Guides, FDA Looking at Single-Page Versions

    • 26 April 2012
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    Comments on the US Food and Drug Administration's (FDA) Medication Guide requirements for prescription drug labeling indicate displeasure with the requirements, which are referred to as onerous, costly, excessive, poorly executed and otherwise burdensome. The comments, contained in FDA's Federal Register posting, entitled Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Prescription Drug Product Labelin...
  • Feature ArticlesFeature Articles

    Regulatory Environment Changes Affect REMS

    To maintain the appropriate regulatory strategy for a product, it is important to stay abreast of continuing changes in the regulatory environment and applicable regulatory requirements. Knowing when regulatory requirements have changed because authorities have deemed an alternative to be sufficient to achieve the same goals can reduce wasted effort and costs for sponsors. One US Food and Drug Administration (FDA) requirement that has undergone an important change is th...
  • New ISO/IEC Guide Addresses Medical Device Safety Regulations

    A new guide put forth by the International Standards Organization (ISO) and the International Electrotechnical Commission (IEC) aims to address medical device safety by guiding the development of new safety standards. ISO/IEC Guide 63:2012,  Guide to the development and inclusion of safety aspects in international standards for medical devices , seeks to improve upon earlier ISO guides by promoting the "optimal use of resources" through limiting the development of...