On 19 December 2016, the European Medicines Agency (“EMA”) published an updated version of the EMA guidance document concerning post-authorisation procedural advice for users of ...24 January 2017
CMS Innovation Center Launches New Medicare ESRD Shared Savings Program
Through this initiative, CMS plans to test the hypothesis that comprehensive medical management of, and better care coordination for, ESRD beneficiaries will result in improved outcomes and reduced costs. The CMS Innovation Center anticipates funding between 10-15 entities, similar to Accountable Care Organizations (ACOs), called ESRD Seamless Care Organizations (ESCOs). Each ESCO must have participant-owners that include a dialysis facility, a nephrologist/nephrology group practice, and another Medicare enrolled provider/supplier that is not a Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) supplier, an ambulance supplier, or a drug and/or device manufacturer. Through these entities, providers will take responsibility for the quality and costs of care provided to patients with ESRD, and will generally share in both savings and losses generated through the program. Mirroring the ACO model, CMS expects ESCOs to provide beneficiaries with a patient-centered, coordinated care experience, and beneficiaries who are matched to an ESCO will stay in fee-for-service Medicare.
The Request for Applications is available online. Letters of intent must be submitted by March 15, 2013. While the letter is non-binding, only applicants that have submitted a letter of intent will be permitted to submit a full application. Applications must be submitted by May 1, 2013.
Regulation (EU) No 536/2014 of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC (“the Clinical Trials Regulation”) was...24 January 2017
The UK Medicines and Healthcare products Regulatory Agency (“MHRA”) has published a draft strategy for developing pharmacopoeial public quality standards for biological...20 January 2017