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
Comparative Effectiveness Research Institute Announces $96 Million in Grant Funding
- Assessing different prevention, diagnosis, and treatment options;
- Improving health care systems;
- Comparing approaches to communication and dissemination of CER information; and
- Addressing and potentially eliminating disparities across patient populations.
A separate PFA regarding $24 million of grant funding will be issued this summer for the fifth focus area: accelerating patient-centered and methodological research.
PCORI is an independent, non-profit organization created by Congress in the 2010 federal health reform law to fund CER that will enable patients, their caretakers, clinicians, and other system stakeholders to make more informed health care decisions. PCORI formally amended its research agenda on May 21, 2012, after receiving over 450 public comments on its draft research agenda.
For the first four focus areas, the online application system will open on June 1, 2012 at the following web address http://www.pcori.org/funding-opportunities/pfa/. Letters of intent are due June 15, 2012; applications are due July 31, 2012.
PCORI has posted application guidelines and review criteria for potential applicants. Successful applicants must have research teams with patients, caregivers, and practicing clinicians actively engaged throughout the process, from generating research questions to conducting research and using the results to understand and address patient needs. PCORI intends to support projects which promote transparency, replication, and reproducibility in research to help build confidence in the accuracy of research findings. Research may focus on patient or system enrollee populations with a single condition or a range of conditions. Research strategies to support or improve care for patients with rare conditions are also of interest.
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