• Australia Proposes Changes to How Sponsors Amend Approved Prescription Applications

    Australia's Therapeutic Goods Administration (TGA) announced on 12 June the impending release of proposed changes to how sponsors of registered prescription medications can make "minor variations" to the medicine's entry in the Australian Register of Therapeutic Goods (ARTG). TGA said the changes typically fall under one of four categories: corrections to the entry, a safety-related changes, "self-assessable" quality-related changes or Category 3 quality-level changes. T...
  • GHTF Proposes New Harmonization of Medical Device Audits

    The Global Harmonization Task Force ( GHTF ), a medical device-focused regulatory harmonization organization which counts among its members many of the world's top regulatory agencies, announced a new proposed medical device standard aimed at introducing a grading system to be used during regulatory audits by regulatory authorities and auditing organizations. The proposed document, SG3(PD)/N19: Quality Management System - Medical Devices - Nonconformity Grading System ...
  • FDA: New OTC Switch Paradigm Would Require New Regulations

    The US Food and Drug Administration (FDA) held a hearing on Friday, 23 March on the prospect of creating a new paradigm for switching more prescription medications to over-the-counter (OTC) status in a move it claims could "increase availability of OTC medicines" to consumers. FDA is particularly concerned about the conditions in which such an OTC switch would be warranted and how to ensure patients use a medication safely. "For example, before getting a medication, you...
  • Hearings to Explore Budget, Prescription Drug Issues

    A trio of Congressional hearings the week of 27 February will explore the proposed budget of the US Food and Drug Administration (FDA), the proposed budget of the US Department of Health and Human Services (DHHS) and prescription drug diversion. On 29 February 2012, FDA Commissioner Margaret Hamburg will appear before the US House Committee on Appropriations . Hamburg will be joined by FDA Assistant Commissioner for Budget Patrick McGarey and Deputy Assistant Secretary ...
  • Health Agency Releases Regulatory Agenda Update, Includes FDA Regulations in Development

    The US Department of Health and Human Services released their semiannual regulatory agenda on 13 February, which is an "inventory of rulemaking actions under development throughout [DHHS] with a view to offering summarized information about forthcoming regulatory actions for public review." The regulatory agenda includes numerous US Food and Drug Administration (FDA) activities in the pre-rule, proposed rule, final rule and long-term stages of development. Notably, F...
  • GHTF Releases Proposed Changes to SG5 Clinical Performance Studies for IVDs

    The Global Harmonization Task Force released a new proposed document for their Study Group 5 (SG5) category called " Clinical Performance Studies for In Vitro Diagnostic Medical Devices ." The document provides guidance for IVD medical devices, including the selection of clinical performance study design and the considerations to be made when undertaking those studies. The document notes that "As IVD medical devices are used on specimens taken from the human body, th...
  • FDA Releases Study on Major Statements in DTC Advertising, Reopens Comment Period on Proposed DTC Regulation

    The US Food and Drug Administration (FDA) released the results of a new study on 27 January that explores the impact of distraction on a consumer's understanding of important information in direct-to-consumer (DTC) television advertising. The study , Experimental Evaluation of the Impact of Distraction on Consumer Understanding of Risk and Benefit Information in Direct-to-Consumer Prescription Drug Television Advertisements , was conducted in response to a proposed...
  • Proposed FDA Rule Would Amend Citizen Petition Regulations

    On 3 January the US Food and Drug Administration (FDA) released a new proposed amendment via the US Federal Register that would amend the regulations governing the process for citizen petitions, petitions for stay of action, and the submission of documents to the FDA. The proposed rule would amend the way the FDA deals with section 505(q) of the Federal Food, Drug and Cosmetic Act (FD&C Act), which regulates how the FDA responds to citizens petitions and petitions ...