Food and Drug Administration

Latest stories

  • Immuron, Naval Medical Research Center Partner to Test Supplement Against Stomach-Ailing Bacteria - top government contractors - best government contracting event
    in Industry News, News

    Immuron, Naval Medical Research Center Partner to Test Supplement Against Stomach-Ailing Bacteria

    Australia-based Immuron has entered a research and development collaboration agreement with the Naval Medical Research Center to test the bio-pharmaceutical company’s drug against gastrointestinal problems. The company said Aug. 30 it will test the Travelan dietary supplement against Campylobacter and Enterotoxigenic Escherichia coli gram-negative bacteria to help develop therapeutics in an effort to protect military and civilian populations from diarrhea. Immuron and NMRC researchers […] More

  • Takeda Subsidiary Lands HHS Contract to Develop, Test Zika Vaccine - top government contractors - best government contracting event
    in Healthcare IT, News

    Takeda Subsidiary Lands HHS Contract to Develop, Test Zika Vaccine

    A U.S. subsidiary of Takeda Group has received an initial $19.8 million contract from  the Department of Health and Human Services to develop and test a Zika virus vaccine over the next 18 months. HHS’ Biomedical Advanced Research and Development Authority will provide funds to help Takeda Vaccines complete process development and preclinical tests of the company’s vaccine candidate against the virus, HHS […] More

  • HHS to Back Chembio Diagnostic Systems' Zika Virus Test Development; Richard Hatchett Comments - top government contractors - best government contracting event
    in Industry News, News

    HHS to Back Chembio Diagnostic Systems’ Zika Virus Test Development; Richard Hatchett Comments

    The Department of Health and Human Services has awarded Chembio Diagnostic Systems $5.9 million in initial contract funds to develop a lateral-flow serological test to identify antibodies produced by the human immune system in response to Zika virus. HHS’ Biomedical Advanced Research and Development Authority will provide the funds to support the test’s continued development, manufacturing preparations and […] More

  • OraSure Awarded HHS Contract for Zika Diagnostic Test Development - top government contractors - best government contracting event
    in Industry News, News

    OraSure Awarded HHS Contract for Zika Diagnostic Test Development

    The Department of Health and Human Services has awarded a potential $16.6 million contract to Orasure Technologies to develop a Zika virus test that will work to show results within 30 minutes and can be conducted at a doctor’s office. HHS said Tuesday OraSure will design its lateral flow serological test to look for Zika antibodies in drops of blood to detect […] More

  • InBios Receives HHS Funds for Zika Diagnostic Test Development; Nicole Lurie Comments - top government contractors - best government contracting event
    in Healthcare IT, News

    InBios Receives HHS Funds for Zika Diagnostic Test Development; Nicole Lurie Comments

    InBios International has received a two-year, $5.1 million contract from the Department of Health and Human Services to further develop a blood screening technology intended to identify people infected with the Zika virus. HHS’ Office of the Assistant Secretary for Preparedness and Response will fund the serological test being developed by InBios with the goal to speed up […] More

  • Salient CRGT Promotes John Edgar as SVP; Kevin Bahumian & Anuj Mathur to VP - top government contractors - best government contracting event
    in News

    Salient CRGT Promotes John Edgar as SVP; Kevin Bahumian & Anuj Mathur to VP

    Salient CRGT has elevated John Edgar, former company vice president and chief strategist for information technology transformation, as a senior VP while Kevin Bahumian and Anuj Mathur have been promoted to the roles of vice president from their former directorial positions. The software development and technology services company said Thursday Edgar will continue to manage Salient’s innovation centers and provide leadership […] More

  • FDA Seeks Info on COTS Quality Management Software Sources - top government contractors - best government contracting event
    in Healthcare IT, News

    FDA Seeks Info on COTS Quality Management Software Sources

    The Food and Drug Administration has sought information on potential industry sources that can provide a commercial off-the-shelf software platform designed to help FDA compile audits and assessments as well as detect and monitor preventive and corrective actions. FDA said in a FedBizOpps notice posted Friday the proposed Quality Management Information System should be designed to capture […] More

  • FDA OKs Emergency Use of Hologic's Zika Virus Diagnostic Tool - top government contractors - best government contracting event
    in Industry News, News

    FDA OKs Emergency Use of Hologic’s Zika Virus Diagnostic Tool

    Massachusetts-based medical technology developer Hologic has received emergency use authorization from the Food and Drug Administration for a device the company developed to help clinicians detect Zika virus infections. Hologic said Friday its Aptima molecular diagnostic assay is designed for qualitative detection of ribonucleic acid from the mosquito-borne virus in human blood samples. The assay is based on the company’s Panther system that works to […] More

  • CMS, FDA Vet Mark McClellan Joins American Well as Advisory Board Vice Chairman; Ido Schoenberg Comments - top government contractors - best government contracting event
    in News

    CMS, FDA Vet Mark McClellan Joins American Well as Advisory Board Vice Chairman; Ido Schoenberg Comments

    Mark McClellan, director of the Health Policy Center at Duke University, has joined telehealth technology and services company American Well as vice chairman of the advisory board. McClellan previously served as director of the Health Care Innovation and Value initiatives at Brookings Institution and managed the Richard Merkin program on payment reform and clinical leadership, […] More

  • NIST, Stanford University Enter Partnership to Foster Biotech Measurement Infrastructure - top government contractors - best government contracting event
    in Industry News, News

    NIST, Stanford University Enter Partnership to Foster Biotech Measurement Infrastructure

    The National Institute of Standards and Technology will collaborate with Stanford University to develop measurement units for biotechnology products and services in sectors such as healthcare, energy and electronics. NIST said Friday the NIST-Stanford Joint Initiative for Metrology in Biology looks to engage academia, industry and government in the development of tools that would help establish units of measurement for […] More

  • HHS, FDA Vet Melissa Chapman Joins Triple-i as BD, Capture Unit VP - top government contractors - best government contracting event
    in News

    HHS, FDA Vet Melissa Chapman Joins Triple-i as BD, Capture Unit VP

    Melissa Chapman, a former chief information officer and deputy assistant secretary from the Department of Health and Human Services, has joined Springfield, Virginia-based information technology services company Information Innovators Inc. as new vice president of the business development and capture unit. Chapman joined the company in May and has since led its HHS market growth strategy through subject matter and technical […] More

  • HumanTouch to Support CDC, FDA Through New Atlanta Office - top government contractors - best government contracting event
    in Healthcare IT, News

    HumanTouch to Support CDC, FDA Through New Atlanta Office

    HumanTouch has established an office in Atlanta, Georgia to provide help desk and information technology support services to the Food and Drug Administration and the Centers for Disease Control and Prevention. The company said Monday it will support health IT operations of both the FDA and CDC from the company office as part of two federal contracts the company holds positions […] More