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  • Feature ArticlesFeature Articles

    Mistake-Proofing the Workplace

    This article discusses mistakes, or human errors, made in the pharmaceutical or medical device workplace and provides the definition of a mistake. The authors also present how mistakes are made, whether such errors are the actual "root cause" of defects, the social and company consequences of errors, and what can be done to minimize errors. Introduction On his first job working for a large pharmaceutical company, one of the authors, Max Sherman, was responsible for th...
  • Regulatory NewsRegulatory News

    Biomarker Qualification: FDA Explains Process and Opportunities for Engagement

    In a set of newly released presentations, officials from the US Food and Drug Administration (FDA) explain changes to the agency's biomarker qualification program and detail early opportunities for biomarker developers to engage with FDA. "A qualified biomarker can be used in multiple drug development programs without the need for [the Center for Drug Evaluation and Research] CDER to reconfirm the suitability of the biomarker's qualified context of use," said Marianne No...
  • Regulatory NewsRegulatory News

    CDRH to Launch 'Critical to Quality' Pilot Program

    The US Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH) will lead a pilot program to define characteristics of a device that are critical to product quality and how these characteristics are controlled in design and manufacturing prior to the postmarket inspection. The voluntary pilot, which will run from 29 September to 31 December 2018, invites firms submitting a Premarket Approval Application (PMA) to consider participating ...
  • Regulatory NewsRegulatory News

    EMA Updates Guidance on Three Post-Authorisation Activities

    The European Medicines Agency (EMA) announced Friday it has updated three post-authorisation activity guidance documents, including type II variations, post-authorisation safety studies and quality variations. "The main aim is to improve the quality of post-authorisation applications by better assisting applicants in complying with the legal and regulatory requirements and avoiding frequent mistakes," EMA writes. Specifically, the updates include a new pre-submission c...
  • Feature ArticlesFeature Articles

    Quality Certificates for Small Molecule Drug Product Applications for International Regulatory Submissions

    This article provides a global overview of the general requirements and issues regulatory professionals may encounter while arranging for a variety of certificates for applications for small molecule drug products to be marketed internationally in the EU, US, Canada, Australia and Japan. Introduction From clinical trials to marketing authorization, regulatory dossiers for small molecule drug products are incomplete without the presentation of certain regulatory certif...
  • Feature ArticlesFeature Articles

    ICH Q12 Post Approval Change Management Protocol: Advantages for Consumers, Regulators and Industry

    This article discusses the latest draft of ICH Q12 and significance of harmonizing regulatory requirements across regional borders. It emphasizes how Post-Approval Change Management Protocol (PACMP) can be used as a tool to improve strategic change management and ensure supply chain reliability. 1, 2 Introduction While the pharmaceutical industry is globalized, regulations are regionalized. This means a Marketing Authorization Holder (MAH) can manufacture a product a...
  • Regulatory NewsRegulatory News

    FDA Official Highlights Foreign Supply Chain Challenges

    Drugmakers should be mindful of the risks involved with relying on foreign manufacturers as part of their supply chain, said Thomas Cosgrove, director of the US Food and Drug Administration's (FDA) Office of Manufacturing Quality within the Center for Drug Evaluation and Research. Speaking at the Food and Drug Law Institute's annual conference on Friday, Cosgrove detailed some of the biggest challenges drugmakers face when contracting with foreign manufacturers, which fi...
  • Feature ArticlesFeature Articles

    Thailand's Approach to Drug Quality Assurance: Creation of the Green Book

    This article discusses how Thailand's Ministry of Public Health (MOPH), Food and Drug Administration (Thai FDA) and a number of government and independent health agencies regulate drugs, both new and generic, as well as traditional, nonwestern medicines. Regulatory System Overview Thailand's health system is regulated by the MOPH and the Thai FDA in collaboration with a number of government and independent health agencies. The MOPH is responsible for all health-relate...
  • Regulatory NewsRegulatory News

    CDER Officials: Nanomaterial Submissions on the Rise

    A team of officials from the US Food and Drug Administration's (FDA) Office of Pharmaceutical Quality within the Center for Drug Evaluation and Research (CDER) say that submissions for drugs containing nanomaterials are on the rise. The finding stems from an analysis published Monday in Nature Nanotechnology , in which the officials look at trends in submissions involving nanomaterials over the last 40 years. In the analysis, the authors say the number of investigation...
  • Regulatory NewsRegulatory News

    EMA-FDA QbD Pilot Program Led to Further Harmonization

    The European Medicines Agency (EMA) and US Food and Drug Administration (FDA) have wrapped up a joint pilot program assessing applications containing Quality by Design (QbD) elements that led to further hamornization of concepts introduced through the International Council for Harmonisation (ICH). Background The joint pilot program, initially launched in March 2011 for three years, was extended for two more years in 2014 to facilitate further harmonization of per...
  • Regulatory NewsRegulatory News

    Researchers Link Target Product Profiles to Shorter Review Times

    A recent analysis finds that drug and biologic submissions to the US Food and Drug Administration (FDA) that reference a target product profile (TPP) are associated with shorter review times at the agency. The analysis was published in Cell Press earlier this month by Christopher Breder, a medical officer within FDA's Office of New Drugs and adjunct faculty at Johns Hopkins University's regulatory science program and two students in the program, Wenny Du and Adria Tynd...
  • Regulatory NewsRegulatory News

    Industry Wants FDA to Hit the Brakes on Quality Metrics Program

    The US Food and Drug Administration's (FDA) proposed quality metrics program is proving to be a bitter pill for the pharmaceutical industry to swallow. Months after FDA revised its draft guidance in response to industry concerns, a consortium of industry groups, including the Association for Accessible Medicines (AAM, formerly GPhA), the Pharmaceutical Research and Manufacturers of America (PhRMA), International Society for Pharmaceutical Engineering (ISPE), Bulk Pha...