-
New FDA/EMA Rare Diseases And Patient Engagement Clusters Underway
FDA Blog | The FDA has announced a new cluster with the EMA to advance treatments for patients with rare diseases.
Oct 18, 2016
-
FDA Awards 21 Grants To Stimulate Product Development For Rare Diseases
Clinical Informatics News Brief | The FDA announced yesterday that it has awarded 21 new clinical trial research grants totaling more than $23 million over the next four years to boost the development of products for patients with rare diseases.
Oct 18, 2016
-
The Fine Print of MACRA’s Final Rule: Good for Patients?
THCB | The Centers for Medicare & Medicaid Services (CMS) just released the final regulations for the most ambitious attempt in U.S. history to transform how medical care is delivered and paid for. But is it good for patients?
Oct 17, 2016
-
As Apple Watch tops Cleveland Clinic accuracy trial hints emerge about its future
MobiHealthNews | It's been a big couple of days for Apple's Apple Watch, which came out ahead in a small study published in the Journal of American Medical Association Cardiology journal yesterday. Additionally, news broke today of two patents that could predict some intriguing future features for the device, and Politico reported on a potential new healthcare use case with the device.
Oct 14, 2016
-
A Letter from CMS to Clinicians in the Quality Payment Program We Heard You and Will Continue Listening
THCB | Andy Slavitt writes that CMS has listened to clinician feedback in finalizing the implementation of MACRA. "The policy released today is the first step in a multi-year journey in which we are particularly focused on allowing clinicians to transition at their own pace," he says.
Oct 14, 2016
-
Veeva Systems Announces EDC, eSource, And Expansion Of Its Leadership Team
Clinical Informatics News Brief | Veeva announces EDC and eSource to improve the speed and quality of data to cut cost and complexity in clinical trials. Veeva has also expanded its leadership team across product management and cloud software development.
Oct 13, 2016
-
Where We Are/What We Have Done – Two Years After Releasing Our FDASIA 907 Action Plan
FDA Voice | Janice Soreth shares updates on the FDA's plan to advance the inclusion of diverse populations in clinical trials.
Oct 11, 2016
-
FDA’s Oncology Center of Excellence to Innovate Regulatory Approaches for Cancer Therapies
Clinical Informatics News | Speeding therapies to market is at the heart of the newly organized Oncology Center of Excellence (OCE), an initiative meant to support an integrated approach to evaluating products for cancer detection, diagnosis, prevention, and treatment. Committed to meeting the needs of patients, OCE, a virtual center within the Food and Drug Administration (FDA), will coordinate and review all cancer treatments coming before the agency—drugs, biologics, and diagnostics—instead of continuing with separate review in different silos.
Oct 11, 2016
-
A Little-Known Drug Company Could Have The Answer For Some Alzheimers Patients
Forbes | Even if ALZ-801 proves to be effective in 15% of AD patients, it would be a big breakthrough in a disease where a breakthrough is desperately needed.
Oct 7, 2016
-
Finalists for Astellas's C3 Prize Announced
Clinical Informatics News | Astellas Ocology has announced five finalists for its C3 prize. The finalists include Prostmate, OnComfort, and Bioinformatix’s Rx&You.
Oct 6, 2016
-
New Recommendations for Improving AE Reporting in Clinical Trial Publications
Clinical Informatics News | A group of stakeholders recently published a list of recommendations in BMJ to improve adverse event reporting in clinical trial publications.
Oct 5, 2016
-
Ridesharing for Health: How On Demand Cars Could Improve Care
Clinical Informatics News | Last week Boston-based startup Circulation announced its non-emergency medical transportation pilot program in conjunction with Uber. The pilot program is testing Circulation’s transportation platform at hospitals and care facilities in Boston, Delaware, and Pennsylvania.
Oct 5, 2016
-
Stop Choosing Between Clinical Supply Waste and Supply Chain Risk to Inform Forecasting Decisions
Clinical Informatics News Contributed Commentary | Clinical trials are becoming more complex as new designs are introduced. The challenge in clinical supply forecasting is to set the threshold of supplies for enrolling sites as low as possible but as high as necessary, taking into account all variable factors as well as required stocking of the depots, expiration date and the overall availability of the clinical drug.
Oct 4, 2016
