• Focus' Federal Register Tracking Tool for the Life Science Industry (Updated 25 July 2013)

    Notice: This page is no longer being updated. The Federal Register Tracking Tool can now be found at the following link, where it is updated regularly:  http://www.raps.org/focus-online/federal-register-tracking-tool.aspx Here at Regulatory Focus , we read the US government's Federal Register like some people check their Facebook pages, which is to say obsessively. When it comes to keeping track of what the US Food and Drug Administration (FDA) is doing - f...
  • NIH Opens up Supplement Labels to Public Researchers, Industry

    Consumers and industry alike have long been able to look up the approved labeling for prescription medication using the US Food and Drug Administration's (FDA) Drugs@FDA online database. Starting today, the National Institutes of Health (NIH) is making the labeling for a related class of products available as well: Dietary supplements. Background: Supplement Requirements Drug and supplement labeling are different from one another, with the former strictly regulated dire...
  • Federal Register Tracking Database

    Date Title In Focus Federal Register FDA Link 3 January 2013 Draft Revision of Guidance for Industry on Providing Regulatory Submissions in Electronic Format-Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications Here Here Guidance 4 January 2013 Advisory Committee for Reproductive Health Drugs Here Meeting 4 January 2013 Medical Imaging ...
  • Health Canada Releases New Clinical Trials Transparency Database

    Health Canada has announced the launch of a new online clinical trials transparency database, a tool similar to the US' ClinicalTrials.gov database that now contains basic information about clinical trials and the conditions for which a drug product is being studied. Background The impending launch of the database was first announced in December 2012 by Health Canada, which said it was aiming for an April 2013 start date. Registration will be required of all trials ...
  • Regulatory Intelligence Firm Graematter Gets Major Funding to Navigate Complex FDA Environment

    As any regulatory professional can attest, finding information on the US Food and Drug Administration's (FDA) website is difficult-really, really difficult, even. So difficult, in fact, that it has inspired the creation of a new regulatory intelligence company, Graematter , that's already attracting attention and significant amounts of funding from members of the medical device and pharmaceutical industries. 'Information Overload' The company, founded by Melissa Walke...
  • Health Canada Launching Clinical Trials Transparency Database

    Health Canada will soon make public key information on clinical trials conducted by industry in the country, introducing a measure of transparency that is ultimately meant as a half-step toward still greater measures. The 26 April 2013 statement explains that Health Canada is informing all clinical trials sponsors that essential data on pharmaceutical trials will be published starting in May 2013, "and will include trials that were issued a No-Objection-Letter (NOL) as o...
  • Civil Rights Group Argues for Protection of Prescription Databases

    The American Civil Liberties Union (ACLU), a constitutional and legal advocacy group, is filing a lawsuit against the Drug Enforcement Administration (DEA) in light of what it calls a constitutionally dubious encroachment on the prescription drug use records of US citizens. In a statement posted to its website on 25 January 2012, the organization said it had been made aware of DEA's efforts to "access private prescription records of patients in Oregon without a warrant, ...
  • Europe-wide HTA Database Opened for HTA Agencies

    • 09 November 2012
    A new first-of-its-kind database, the European Evidence Database on New Technologies ( EVIDENT ), is now accessible for all government-appointed Health Technology Assessment (HTA) agencies in Europe, related regional agencies and not-for-profit organizations. The database permits HTA agencies to register Additional Data Collection (ADC) studies they have undertaken to fill gaps in HTA-related information as well as search for studies being registered by other HTA agencie...
  • Regulatory Transparency Measures Lead to False Alarms

    What happens when regulatory databases are made easier to access and understand? In at least one instance of irony, just the opposite of what might be expected. Australia's Therapeutic Goods Administration (TGA) on 1 August 2012 sent out a media advisory after receiving what it said were reports of a news story indicating influenza vaccines were unsafe. Quite the contrary, said TGA. "In fact, there have been no recorded deaths from influenza vaccine in Australia," regu...
  • Feature ArticlesFeature Articles

    ClinicalTrials.gov: Requirements and Implementation Strategies

    The Food and Drug Administration Amendments Act of 2007 ( FDAAA ) established a requirement for certain clinical trials to be registered at trial initiation and to report summary results after trial completion in the public registry and results database called ClinicalTrials.gov . This law is intended to facilitate enrollment in clinical trials, allow for tracking of the progress of such trials and address problems with the lack of timely dissemination of research fi...
  • C-Path Initiative's Work on Personalized Medicine Starts to Get Results

    The Critical path Institute (C-Path), the US Food and Drug Administration (FDA)-supported public-private initiative working to advance personalized medicine, is advancing quickly and is bearing results, reports The Arizona Star . C-Path, now under the leadership of President and CEO Dr. Carolyn Compton, is working with numerous private companies to create technologies to develop safer, more effective drugs. "The idea here is, through the creation of new tools, new meas...
  • MHRA: New Clinical Practice Database Will Lead to New Ways to Conduct Clinical Trials

    The Clinical Practice Research Datalink (CPRD), an anonymized longitudinal medical records database, is being launched to provide the UK life-sciences industry with a "world-class" health service that may well revolutionize the way clinical trials are conducted, the Medicines and Healthcare products Regulatory Agency (MHRA) said in a statement. The MHRA-managed CPRD "will help researchers to better understand the causes of illness and protect public health while ensuring...