• Commonwealth Awarded FDA Contract for Safety Signal Detection

    Clinical Informatics News  Commonwealth Informatics announced this morning that it has been awarded a contract by the Food and Drug Administration to provide consulting services and technical assistance to the FDA Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) to support their use of the Empirica Signal software for quantitative safety signal detection and safety signal management.

    Jun 20, 2016

  • Zika vaccine receives first FDA approval for clinical trial

    STAT |  The approval marks an early but significant step in the effort to combat a disease that has quickly emerged as a global health threat.

    Jun 20, 2016

  • Paratek Shares Climb After Antibiotic Clears First Phase 3 Hurdle

    Xconomy |  Paratek Pharmaceuticals has stuck with its antibiotic omadacycline over the years, even as three of the company's pharmaceutical partners bailed on the drug. Today the company said that omadacycline hit all its main and secondary goals in a late stage trial.

    Jun 17, 2016

  • Women Are Being Excluded From Clinical Trials

    Popular Science |  An editorial out this week in the British Journal of Sports Medicine says that women have been routinely excluded from clinical trials due to, "complexities of the menstrual cycle."

    Jun 15, 2016

  • FDA Launches Clinical Trial Minority Participation Campaign

    Clinical Informatics News | On Sunday the Food & Drug Administration is launching the first phase of a campaign to encourage minorities to participate in clinical trials. With a series of six videos, blogs, and an infographic, FDA hopes to increase awareness about clinical trials in minority communities and encourage discussion and participation.

    Jun 15, 2016

  • FDA's Guidance on Sharing Patient Information from Medical Devices

    FDA Law Blog |  On June 10, FDA issued the draft guidance, "Dissemination of Patient-Specific Information from Devices by Device Manufacturers." At a mere six pages long, this guidance is not tipping the scales by any means, but its pages contain some important information for device manufacturers.

    Jun 15, 2016

  • Drug firms seeing greater success with clinical trials

    STAT |  Drug firms may be seeing improved success in their clinical trials, but whether that trend is sustainable is an open question, an analysis says.

    Jun 14, 2016

  • Obamas choice to waive HIPAA in Orlando will likely help families and loved ones during the crisis.

    Slate Magazine |  Over the last two decades, the term HIPAA has effectively become synonymous with medical privacy. But guarding medical privacy was not, and is not, its only goal. HIPAA was enacted to facilitate the necessary flow of health information while taking care not to compromise patient control.

    Jun 13, 2016

  • ePatientFinder raises $8 million for its cloud-based clinical trial exchange platform

    MobiHealthNews |  Austin, Texas-based ePatientFinder raised $8.2 million to build out its Clinical Trial Exchange platform.

    Jun 13, 2016

  • Transparency Life Sciences Wants to Change How We Design and Execute Clinical Trials

    Clinical Informatics News | Since its founding in 2010, Transparency Life Sciences (TLS) has been on a mission: to build a culture and a platform for moving clinical trials out of the existing healthcare system. It plans to accomplish this via new methods for designing and executing clinical trials through the use of  crowdsourcing and digital technology.

    Jun 6, 2016