Posts Tagged ‘Open’

31
May

FDA/NIH Open Safety Reporting Portal to Public

The FDA and NIH have unveiled a new website that will one day be the central place for reporting on safety issues with foods, drugs, devices, and many other products. Currently to properly report on a product requires submitting forms to different agencies and the new website will try to streamline and centralize the process.

From FDA’s press release:

The new Web portal includes different features for different types of reporting:

  • Reportable Food Registry: Industry will have a more user-friendly electronic portal for submitting reportable food reports that are required by law. This electronic portal collects reports from the food industry and public health officials regarding problems with articles of food, including animal feed, that present a reasonable probability of causing serious adverse health consequences or death to humans or animals.
  • Pets: Pet owners and veterinarians will be able to use the portal to report product problems with pet foods and pet treats.
  • Animal drugs: Animal drug manufacturers can report adverse drug events associated with animal drugs.
  • Clinical Trials: Biomedical researchers involved in human gene transfer clinical trials can report an adverse event, indicating whether it might be an unanticipated consequence of the product being tested. Trial sponsors can use the portal to prepare a report, print it and send it to the agency to satisfy reporting requirements for investigational new drugs.
  • In the future, the system will encompass other types of clinical trials and, eventually, safety problems arising from products regulated by a broad array of federal agencies. This is a first step toward a common electronic reporting system that will offer one-stop shopping, allowing an individual to file a single report to multiple agencies that may have an interest in the event.

    Link: Safety Reporting Portal…

    Press release: FDA and NIH Launch Electronic Safety Reporting Portal…



    29
    May

    Open Source Drug Discovery May Find Compounds for Malaria, Other Poor Man’s Diseases

    vas3423.jpgGlaxoSmithKline has begun an experiment with open-source development of malaria drugs by releasing the structural and activity data for 13,500 compounds that may be good candidates for further study. The Wall Street Journal profiles Collaborative Drug Discovery (CDD), a Silicon Valley company, that’s hosting much of the data about these compounds. Essentially CDD provides free access to a social network style interface and access to a large database, harnessing the power of groups to find needles in a haystack.

    From WSJ:

    CDD’s Web service combines elements of a Facebook-like social network with an Oracle-style database. Any researcher who registers on the CDD site will be able to see graphical depictions of Glaxo’s compounds and relevant chemical and biological data. The database will allow them to upload their own data to be viewed by other researchers.

    The service is free of charge. If a researcher wants to combine the data with proprietary information, CDD alsooffers a fee-based, secure version of its site that allows researchers to lock up information they want to keep secret.

    Researchers including James McKerrow, a professor at the University of California, San Francisco, have used CDD since 2007 to share data about diseases including malaria and schistosomiasis, a parasite that can cause liver and kidney damage. The group shared data on tens of thousands of compounds to speed up the process of picking a handful of compounds (for diseases such as malaria) that are the best options to try on animals, Dr. McKerrow said.

    Demo of CDD’s software:

    Read on at WSJ: Glaxo Tries a Linux Approach

    More from CDD: GSK and Online Communities Create Unique Alliance to Stimulate Open Source Drug Discovery for Malaria

    Link: CDD Public Access Data



    4
    May

    RobuBOX-Kompai Now Open to Outside Development

    Robosoft out of Bidart, France is releasing the open source software version for its RobuBOX-Kompaï at-home assistance robot. The mobile platform includes navigation and communication capabilities and is now open to tinkering around by developers trying to extend the potential tasks the robot can perform.

    Kompaï R&D is a modular and open robot, intended to develop assistance applications for use by dependent persons in their daily lives. RobuBOX-Kompaï provides functions such as speech recognition (for understanding simple orders, and to give a certain level of response), localization and navigation (for going from one place to another on demand or on its own initiative), communication (it is permanently connected to the Internet and all its services), automation (for personal monitoring, recognition of gestures and postures) …

    Through the provision of this open source software (LGPL licence), anyone with a Kompaï R&D robot will benefit from the many basic functions that are already in place, and also be able to modify and adapt them, while developing new ones that can be shared with other research teams.

    Press release: robuBOX-Kompaï now available in Open Source…

    Flashback: At-Home Robot Supposedly Helps Elderly Keep Tabs on Life