• Brazil Opens Consultation on 2013-14 Regulatory Agenda

    Brazil's National Health Surveillance Agency (Anvisa) has opened up its 2013-2014 Regulatory Agency for public consultation and comments, it announced this week. The Preliminarily Proposed Themes were developed through discussions held within the agency and target 78 regulatory measures of which 63% were continued from the 2012-2013 Agenda.  The consultation is open to so-called participating entities that are qualified according to the following criteria: an ...
  • Report Claims Staffing Problems Continue to Plague FDA

    The reputation of a federal agency often precedes it. For the US Food and Drug Administration (FDA), the public's perception of its reputation is proving to be a significant impediment to its attempts to recruit the best regulatory staff it can get, says a new report from the Partnership for Public Service (PPS). The group acts as a sort of advocacy group for those working in, or hoping to work in, the government. PPS said it had recently been approached by the Pew Cha...
  • UK Opens Consultation on Proposed EU Device Legislation

    The UK's Medicines and Healthcare Products Regulatory Agency (MHRA) opened a public consultation on 12 November 2012 on the European Commission's proposals for three new medical device regulations set to replace existing EU directives. The proposals-two on medical devices and one on in vitro diagnostic devices (IVDs)-are still in draft form, and MHRA said it was urging industry and the public to comment on them before they become final. The proposals are a direct resul...
  • FDA in Sustained Push to Show Public Benefits of Regulatory Science

    Can regulatory science -that is, the use of various scientific disciplines to make informed decisions about the safety, efficacy or quality of a particular product-ever be exciting to the average citizen? Regulators with the US Food and Drug Administration (FDA) hope so, and are in the midst of a sustained public relations push to give the burgeoning field a bit more exposure and appreciation. In a posting on 6 November, FDA's Susan Kelly, managing editor of consume...
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    Experts Examine Regulation of Health-Related Mobile Apps, Software and Social Media

    When it comes to the regulation of mobile apps, software and social media in the healthcare space, intent is key but absolute clarity is elusive, according to the expert presenters who spoke to attendees during a session at 2012 RAPS: The Regulatory Convergence in Seattle. The speakers, Center for Medicine in the Public Interest Founder Peter Pitts; Head of Emerging Technologies, Devices Division for the UK's Medicines and Healthcare products Regulatory Agency (MHRA) Ne...
  • Regulators: Need to Pay More Attention to Regulatory Capacity of Developing World

    • 24 October 2012
    Little attention has been paid to the regulatory systems in low- and middle-income countries across the world, causing a huge and negative impact on global public health, argue three employees of the US Food and Drug Administration (FDA) in the latest issue of the Public Library of Science Medicine (PLoS Medicine) . The article, Strengthening Medical Product Regulation in Low- and Middle-Income Countries , was authored by Charles Preston, Mary Lou Valdez and Katherin...
  • In Shift, GSK to Publish Clinical Trials Data

    • 11 October 2012
    Under fire from industry critics, UK drug manufacturing giant GlakoSmithKline has announced its intent to publish clinical trials data-a first for both the company and the pharmaceutical industry, which has historically guarded such data closely to limit potential risk. In a statement, the company said it intends to share, "Detailed clinical trial data to enable additional scientific inquiry and analyses to further scientific knowledge and help bring benefit to patient...
  • Group Calls for REMS-Like Conditions for Popular Hypertension Drugs

    The public safety advocacy group Public Citizen is calling on the US Food and Drug Administration (FDA) to place additional safety warnings and restrictions on several classes of hypertension drugs due to safety concerns. In a petition sent to FDA Commissioner Margaret Hamburg and Center for Drug Evaluation and Research Director Janet Woodcock on 4 October, Public Citizen said three types of hypertension drugs-angiotensin-converting enzyme (ACE) inhibitors, angiotensin...
  • Study: Regulatory Noncompliance Plays Big Role in Record-Setting Fines

    Regulatory compliance woes have contributed to record-setting fines paid by pharmaceutical companies since 1991-more than $30 billion in total -- claims a new report published by the health advocacy group Public Citizen. The report, " Pharmaceutical industry Criminal and Civil Penalties: an Update ," follows an earlier 2012 report by the same group in which it found that nearly $20 billion had been recovered by federal officials from pharmaceutical companies since 1991, ...
  • Group: FDA's Interpretation of FOIA Procedures Illegal

    The public health advocacy group Public Citizen is blasting the US Food and Drug Administration (FDA) for its application of the Freedom of Information Act (FOIA) , saying in a statement that the agency's actions violate both the "letter and spirit" of the law. FOIA , passed in 1966, has been dramatically expanded over the last half century to include numerous provisions requiring federal agencies to release documents relating to many internal decision-making proce...
  • EMA Opens Consultation on Proposed Pediatric Development Framework

    The European Medicines Agency (EMA) is opening a public consultation on a newly released report in which it calls for a new framework to incorporate the views of children into the review of clinical trial plans before the Pediatric Committee (PDCO). The report, " Concept paper on the involvement of children and young people at the PDCO ," is aimed at meeting the requirements of the Charter of Fundamental Rights of the EU, which states that member states should take into ...
  • FDA Highlights Regulatory Science in Outreach to Public

    "When someone uses the word 'science,' you might think of chemistry, biology, or physics, to name just a few fields," writes the US Food and Drug Administration (FDA) on a new webpage aimed at the general public. "You probably wouldn't think 'regulatory science.'" That's something FDA hopes to change, the agency writes. FDA officials are now touting the impact of regulatory science to the public, hoping to make consumers more aware of the complexities of regulating prod...