Joint FDA-NIH Adverse Events Portal Being Developed

Top officials of the Food and Drug Administration and the National Institutes of Health, sister agencies within HHS, have signed an agreement to work together on a joint Web site for reporting adverse events and recalls. The document was posted Dec. 21 on FDA's popular MedWatch site, www.fda.gov/medwatch/, which is being updated into MedWatchPlus, according to the agreement.

The updated MedWatch will be a "portal through which adverse event, consumer complaint, and product problem reports are received and processed to make the information available to adverse event analysis systems," the document says. FDA and NIH agreed to collaborate on development of a "Rational Questionnaire" and a prototype to test the feasibility of a joint portal that allows users to utilize many forms both agencies employ. The "Rational Questionnaire" is described as an interactive help system to assist reporters of information.

The agreement was signed Sept. 27 by Dr. Janet Woodcock, deputy commissioner, chief medical officer in the FDA Office of the Commissioner, and Lana Skirboll, Ph.D., director for science policy in the NIH Office of the Director.

Product Showcase

  • Magellan X Pte Ltd

    Hesitate No More with SOL-X Connected Worker Health & Safety Solution

    According to the National Safety Council, work-related medically consulted injuries total 4.26 million in 2021 in USA alone. SOL-X solution prevents “human factors” safety issues by anticipating incidents and improving compliance workflows. Leverages digital technologies (IIoT, AI and analytics) to predict patterns from occurring and make informed decisions. Control Of Work - gets rid of tedious paperwork and experience digital workflows. Crew Protect - maximises safety and situational awareness with health trackers and situational indicators. Award-winning Intrinsically Safe SmartWatch – innovative features that enable near real-time visibility and connected well-being. Works well with major connectivity protocols like Wi-Fi, Bluetooth, and Long-Range Bluetooth! 3

  • The MGC Simple Plus

    The MGC Simple Plus

    The MGC Simple Plus is a simple-to-use, portable multi-gas detector that runs continuously for three years without needing to be recharged or routinely calibrated after its initial charge and calibration during manufacturing. The detector reliably tests a worksite’s atmosphere for hydrogen sulfide, carbon monoxide, oxygen and combustible gases (LEL). Additionally, it is durable enough to withstand the harshest treatment and environments, which is why it has an IP 68 rating. The MGC Simple Plus is also compatible with a variety of accessories, such as Gas Clip Technologies’ new GCT External Pump. Visit gascliptech.com for more information. 3

Featured