BD follows local regulatory requirements relating to clinical trial registration and results disclosure. In the EU, BD complies with Regulation 2017/745 (EU MDR) or Regulation 2017/746 (EU IVDR), as well as ISO 14155:2020 or ISO 20916:2019 to register and post results of our applicable clinical trials. In the United States, BD complies with the requirements of the Food and Drug Administration Amendments Act (FDAAA) of 2007 (as defined in the FDAAA).
BD commits to seek the publication of the results of our completed applicable clinical trials on any marketed product in peer-reviewed scientific literature, regardless of the trial's outcome. BD supports recognized standards concerning authorship and publication, including those of the International Committee of Medical Journal Editors (ICMJE) and Consolidated Standards of Reporting Trials (CONSORT).
BD may provide the final statistical reports of protocol-derived outcomes to external authors. BD reserves the right to review and comment on draft abstracts, manuscripts, presentations and other communications by external investigators regarding BD-sponsored trials, prior to their submission or public disclosure, to protect intellectual property and confidential information. As study sponsor, BD does not approve or veto such publications.
