• Feature ArticlesFeature Articles

    Fostering diversity and talent: A Pfizer case study

    The Pfizer Global Regulatory Affairs (GRA) – Howard University College of Pharmacy (HUCOP) Advanced Pharmacy Practice Experience (APPE) program fulfills a requirement of the Doctor of Pharmacy (PharmD) curriculum and helps students explore biopharmaceutical industry career options and prepare for their career after graduation, such as pursuing postgraduate training and seeking employment. The HUCOP Preceptorship Program at Pfizer was designed to broadly increase awareness ...
  • Regulatory NewsRegulatory News

    Digital health collaborative aims to build in equity and inclusion

    A newly minted collaborative of industry, government, and patient groups is seeking to develop a set of best practices that will help make digital health measurement technologies work for all users, regardless of gender, race, ethnicity, and other factors.   The Digital Health Measurement Collaborative Community ( DATAcc ), launched in May 2021, is hosted by the nonprofit Digital Medicine Society (DiMe) and brings together more than 30 organizations, including the US F...
  • Regulatory NewsRegulatory News

    FDA Finalizes Guidance on Targeted Therapies in Rare Genetic Subsets

    The US Food and Drug Administration (FDA) on Monday finalized guidance on developing targeted therapies in rare molecular subsets of diseases.   The 9-page guidance finalizes a draft version released in December 2017 and has been updated to incorporate comments submitted to the public docket and includes minor edits to improve clarity.   “By providing clarity on the regulatory and scientific frameworks for product developers, safe and effective targeted treatment...
  • Asian Harmonization Working Party Joins ISO, IMDRF

    The Asian Harmonization Working Party (AHWP) has announced it has been accepted as a member in both the International Medical Devices Regulators Forum (IMDRF) and the International Standards Organization (ISO). AHWP is a non-profit dedicated to the harmonization of medical device regulations, and includes among its members China, India, Saudi Arabia, Korea, South Africa and Pakistan. The organization said IMDRF had extended an invitation for AHWP to join its Forum as ...