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  • Feature ArticlesFeature Articles

    A mandatory dietary supplement registry: Transparency as ‘disinfectant’

    The Dietary Supplement Health and Education Act struck a balance between protecting public safety and promoting consumer access to dietary supplements, but it did not address the Food and Drug Administration’s inability to “see” into the marketplace. This article discusses how a mandatory product listing can benefit the industry through increased transparency and accountability. It outlines criticisms from industry skeptics and provides considerations for legislation of th...
  • Regulatory NewsRegulatory News

    WHO Adopts Weakened Resolution on Drug Price Transparency

    The World Health Organization (WHO) on Tuesday adopted a resolution to urge countries to publicly share the net prices of health products and the costs of clinical trials. The resolution, adopted after three weeks of negotiations, also calls on United Nations member countries to better facilitate the public reporting of patent status information and marketing approval status of health products, as well as to improve national capacities for open and collaborative researc...
  • Regulatory NewsRegulatory News

    Australia Unveils Device Action Plan

    Australia’s Therapeutic Goods Administration (TGA) released a three-part medical device action plan, part of which will make adverse event reports more timely, as well as enhance public awareness on and the agency and device regulatory system. The plan also identifies additional opportunities for TGA to increase transparency, with stakeholder consultations on proposed changes to regulatory requirements and forthcoming guidance materials. Until early 2020, potential c...
  • Regulatory NewsRegulatory News

    UK Seeks to Increase Clinical Trials Transparency

    The UK government issued a policy paper to improve clinical trials transparency in response to 10 recommendations a House of Commons Science and Technology committee report offered in 2018. “Research findings must be communicated in ways that are timely, meaningful and relevant to evidence users,” Parliamentary Under-Secretary of State for Health Baroness Blackwood said, welcoming the chance to address the October 2018 report . “Only with a system which values transpar...
  • Regulatory NewsRegulatory News

    Half of Clinical Trials Fail to Publish Results, UK Report Finds

    Despite UK and EU rules aimed at boosting clinical trials reporting and transparency, a new report by the UK House of Commons’ Science and Technology Committee finds that nearly half of clinical trials fail to publish results.   “Around half of clinical trials are currently left unreported, clinical trial registration is not yet universal in the UK and reported outcomes do not always align with the original study proposal,” the report finds.   Based on these findin...
  • Regulatory NewsRegulatory News

    Transparency: FDA to Release Portions of Redacted Clinical Study Reports

    As part of a push to be more transparent about its decision making and enhance access to data for researchers, the US Food and Drug Administration (FDA) on Tuesday announced it will launch a pilot project to publicly release portions of clinical trial-related summaries from pivotal trials after a drug is approved. The pilot will select up to nine recently-approved new drug applications (NDAs)  whose sponsors volunteer to participate to release the partially redacted ...
  • Regulatory NewsRegulatory News

    Trial Transparency: NIH Says Final Rule From 2017 has Helped

    Almost a year ago, the National Institutes of Health (NIH) made effective a new policy to better disseminate information from NIH-funded clinical trials through ClinicalTrials.gov, and the agency says that so far, it’s seen some improvements. Back in 2007, section 801 of the Food and Drug Administration Amendments Act (FDAAA 801) established a requirement that "applicable clinical trials" must be registered and information must be submitted to Clinicaltrials.gov. ...
  • Regulatory NewsRegulatory News

    Sanofi and J&J Lead the Way With Clinical Trial Transparency, Study Finds

    Clinical trial transparency among large pharmaceutical companies is high, although opportunities for improvement remain, according to a study published Tuesday in the BMJ. Researchers from New York University, Yale, Stanford and the International AIDS Vaccine Initiative reviewed data from more than 45 sources on 505 trials for 14 drugs approved by the US Food and Drug Administration (FDA) in 2014. "On the drug level, about half of FDA-approved drugs have publicly ...
  • Regulatory NewsRegulatory News

    As Transparency on Priority Review Vouchers Fades, Prices Level Off

    In the early days of the priority review voucher (PRV) programs, back in 2014 and 2015, companies publicly disclosed who they sold their PRVs to, how much they cost and which products they were eventually used to speed the review of. But now that 17 PRVs have been issued by the US Food and Drug Administration (FDA), news of PRV sales has slowed to a trickle of SEC filings and the rare press release. Three times already in 2017, with GlaxoSmithKline and Teva’s...
  • Regulatory NewsRegulatory News

    Asia Regulatory Roundup: CFDA Maps Out Regulatory Transparency (28 November 2017)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. India Prepares for Joint National-State Inspections of Manufacturing Plants India has laid the groundwork for joint inspections of drug manufacturing plants by officials from national and state regulatory agencies. Officials will conduct joint inspections whenever a facility seeks a license to make or sell drugs and at risk-determined intervals to check ongoing compli...
  • Regulatory NewsRegulatory News

    FDA Transparency: Gottlieb Outlines What’s Coming

    FDA Commissioner Scott Gottlieb has been at the forefront of the Washington, D.C. conference circuit this week discussing new work that the agency he leads will undertake, with discussions Thursday at a Politico event, a speech Wednesday at the Friends of Cancer Research, a speech Monday at RAPS' Convergence and a speech last week at the National Health Research Forum. On Thursday, Gottlieb highlighted a few upcoming moves that the agency plans to make in terms of t...
  • Regulatory NewsRegulatory News

    States Take on Drug Price Transparency, Gouging

    As the US Congress continues to highlight specific drug price increases rather than adopt wide-reaching legislation to curb such practices, states are taking the matter into their own hands. In California, an Assembly committee on Wednesday moved forward a bill ( SB 17 ) that would shine a spotlight on what the state spends on the most expensive prescription drugs, as well as which drugs have seen the highest year-over-year spending increases. The bill, which pa...