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  • 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

    FDA’s CBER to Forge Stronger Ties With WHO

    The US Food and Drug Administration (FDA) on Tuesday announced it’s forging a cooperative agreement with the World Health Organization (WHO) to support further regulatory systems strengthening, development of new norms and standards and research to advance global access to safe and effective biologics that meet international standards. FDA's Center for Biologics Evaluation and Research (CBER) anticipates providing up to $2 million in FY 2016 to support the project, as w...
  • Regulatory NewsRegulatory News

    House Hearing Focuses on Harm Done by Drug Price Spikes

    The highly anticipated House Oversight Committee hearing on Thursday was not without its fireworks, though beyond the airing of a lot of discontent, few new options for halting drug price increases were brought to the table. About an hour into the hearing, Martin Shkreli, former CEO of Turing Pharmaceuticals, who previously called the increase in price of a toxoplasmosis drug a “very handsome investment,” was escorted out after he used his Fifth Amendment rights to avo...
  • CDRH Whistleblowing Scandal Back in Spotlight as Congress Again Takes Interest

    If US Food and Drug Administration (FDA) officials thought they had finally moved past a scandal that has embroiled the agency's medical device division for years, they apparently thought wrong. This piece has been updated with comment from FDA. See the FDA Comments' section . -Ed. Background On 26 February 2013, the US House Oversight Committee is set to re-examine a 2012 scandal involving FDA's Center for Devices and Radiological Health (CDRH) in which the agency ...
  • Report: Insufficient Regulatory Oversight Partially Responsible for Counterfeit Drugs

    • 22 May 2012
    • By
    An article published in The Lancet Infectious Diseases says nearly one-third of anti-malarial drugs in foreign countries are of insufficient quality, failing measures of chemical composition, adequate packaging or veracity. The National Institutes of Health (NIH)-funded study looked at 1,437 samples of malaria drugs from seven Asian countries and 2,634 malaria drugs from 21 countries in sub-Saharan Africa. Of the samples obtained from the Asian countries, roughly 33%...
  • Europe: EMA Releases New 'Practical Guidance' on Foreign Clinical Trials

    The European Medicines Agency (EMA) yesterday (16 April) published guidance, in the form of a final reflection paper , on ethical and good clinical practice (GCP) aspects of clinical trials conducted outside of the European Union (EU)/European Economic Area (EEA) and submitted in marketing authorization applications to the EU regulatory authorities. The paper, which enters into force on 1 May 2012, is intended to strengthen existing processes to provide assurance to re...
  • EMA Issues New Paper on Advancing Ethical Regulatory Framework for Clinical Trials

    The European Medicines Agency (EMA) released a new reflection paper on how to advance the regulatory framework overseeing clinical trials, including how to strengthen clinical trials oversight. EMA's 16 April Reflection paper on ethical and GCP aspects of clinical trials of medicinal products for human use conducted outside of the EU/EEA and submitted in marketing authorization applications to the EU Regulatory Authorities seeks to "strengthen existing processes to p...
  • Report: India Boosting Ability to Regulate Clinical Trials

    India's regulatory authorities are boosting their ability to enforce regulatory guidelines after years of heightened requirements, reports Outsourcing Pharma . The Central Drugs Standard Control Organization (CDSCO), which regulates the country's pharmaceutical sector, is seeing an increase in "manpower and infrastructure" to help bring their abilities up their new responsibilities, said Indian Minister of Health and Family Shri Ghulam Nabi Azed . The Indian pharmac...
  • FDA Gets High Marks for FOIA Request Transparency

    A report by the House Oversight Committee has found many federal agencies to be deficient when it comes to tracking basic information regarding Freedom of Information Act (FOIA) requests, including the US Department of Health and Human Services (DHHS). The report "found that many federal agencies failed or struggled to transparently demonstrate an ability to track basic information about the processing" of FOIA requests. While DHHS-the parent organization of the ...
  • FDA Releases Final Guidance on Overseeing Clinical Trials

    The US Food and Drug Administration (FDA) released new guidance 27 February on clinical trials oversight occurring after clinical investigation approval (CIA). Guidance for IRBs, Clinical Investigators, and Sponsors: IRB Continuing Review after Clinical Investigation Approval finalizes draft guidance by the same name released by FDA in January 2010. The guidance aims to provide specific recommendations for Institutional Review Boards, sponsors and clinical investig...
  • POGO Lambastes FDA Over Conflict of Interest Report

    The government watchdog group Project on Government Oversight (POGO) has aimed its sights on the US Food and Drug Administration (FDA) over reports that it allowed panelists with potential conflicts of interest to serve as voting members of an advisory committee, even as it took away the voting rights of a vocal critic of the product the advisory committee was voting on.p For further background, please see prior Regulatory Focus coverage here . The group, which calls ...
  • FDA Makes Changes to Bioresearch Monitoring Information System

    The US Food and Drug Administration (FDA) released new updates to the Bioresearch Monitoring Information System (BMIS) on 9 January.  The program is used by FDA to oversee regulated clinical trials. According to FDA, BMIS "provides controls to ensure that clinical investigators meet the requirements of the relevant statutes and regulations governing FDA-regulated products." This, in turn, supports the bioresearch monitoring (BIMO) program. The changes to BMIS ...