The Learning Portal will be under maintenance Saturday, 8 August between 6 AM and 6 PM EST. Portal functionality will be unavailable during this window.
We apologize for any inconvenience caused during this time.

RAPS is closely monitoring developments in the Coronavirus (COVID-19) outbreak. See our public safety page for the latest updates.

 
  • Regulatory NewsRegulatory News

    FDA Issues Draft Guidance on Extending Expiration Dates for Doxycycline Stockpiles

    In response to questions from state health officials, the US Food and Drug Administration (FDA) on Monday issued draft guidance detailing how state emergency health response stakeholders can extend the shelf life of stockpiled doxycycline. Around the country, emergency health response stakeholders, ranging from some state and local organizations to the Centers for Disease Control and Prevention (CDC), stockpile doxycycline for use as a medical countermeasure against an a...
  • Regulatory NewsRegulatory News

    Sentinel, iPod-Based Devices can Match Patients to EHRs in Public Health Emergencies

    A recent study funded by the US Food and Drug Administration (FDA) found that an iPod Touch-based platform and FDA's Sentinel system could be used to accurately track the safety of drugs and vaccines dispensed during public health emergencies. The platform, called the handheld automated notification for drugs and immunizations (HANDI), uses an application running on an iPod touch, fitted with a card reader and barcode scanner, to record patients' information from a drive...
  • FDA Hopes to Leverage Regulatory Science to Protect Public from Nuclear, Radiologic Threats

    The US Food and Drug Administration's (FDA) may be most known for its drug and device approvals intended to treat relatively common ailments-diseases, infections, cancer and inherited conditions-but every so often its activities venture into more exotic areas of regulation. Regulation: The Exciting Stuff Such an area was on display in a 12 August 2013 announcement in which FDA said it had awarded a $5.6 million contract to Harvard University to assess new medical counte...
  • Are Medical Countermeasures Meeting the Potential Needs of Children?

    Is the US government doing enough to protect children from the threat of a medical emergency caused by a chemical, biological, radiological or nuclear accident? Not as much as it could be, concludes a new report just published by the Government Accountability Office (GAO), an intra-government watchdog that regularly assesses programs for deficiencies. Background Since the events of September 2011, federal agencies, and particularly the US Food and Drug Administration (F...
  • Changes Needed to Allow Pediatric Testing of Medical Countermeasures, Report Says

    • 19 March 2013
    • By
    A new report published by the Presidential Commission for the Study of Bioethical Issues calls for the US government to put into place a modified framework that will allow for researchers to conduct pediatric testing of medical countermeasures, part of a framework intended to protect the entire population in the event of an attack using weaponized anthrax or other pathogens. Background The announcement comes nearly a year after the commission first announced it would st...
  • Regulators Grapple With Complexities of Preparing for Nuclear, Chemical Disaster Events

    Back in September 2012, the US Food and Drug Administration (FDA) issued a little-noticed announcement in the Federal Register indicating that it was interested in starting a dialogue with the medical device industry to plan for the type of mass-casualty event-think a dirty bomb, mass explosion or some other chemical-based incident-that could leave thousands of patients, if not more, requiring medical care. The meeting, part of the US Department of Health and Human S...
  • FDA Beefs up Medical Countermeasure Program with new 510(k) Guidance

    The US Food and Drug Administration (FDA) has released a new draft guidance for industry regarding the development of In Vitro devices capable of detecting the presence of several types of dangerous pathogens, its latest effort in a long-running strategy to develop medical countermeasures (MCMs). The guidance, released 9 November 2012, specifically addresses the unique needs of conducting clinical trials on such a device. The clinical testing of products used to tr...
  • Fear of Disease's Deadly Potential Leads to Regulatory Science Initiative

    The US Food and Drug Administration (FDA) plans to hold a meeting on the regulatory science issues surrounding the development of antibiotics to treat Burkholderia pseudomallei  -a dangerous gram-negative bacterial pathogen capable of killing a high percentage of those it infects. FDA is holding the workshop with a number of other agencies-most of which are military-related-in the hopes of developing classes of products known generally as medical countermeasures (M...