Ethics/Regulatory

EMA tightens rules on ‘revolving door’ for committee members and experts

Thursday, May 7, 2015

The EMA has updated its rules on declarations of interests for scientific committee members and experts. The updates further strengthen EMA’s policy by restricting involvement of experts in the scientific assessment of medicines if they plan to take up a job in the pharmaceutical industry. The updates also include a revised guide on how to complete the agency’s declaration of interest form.

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EMA scientific advice leads to higher success rates, shorter assessment times

Tuesday, April 21, 2015

The majority of clinical development plans submitted for scientific advice to the European Medicines Agency (EMA) prior to a marketing authorization application were found not suitable for future benefit-risk assessment. Companies that changed their clinical development plans in accordance with the recommendation from EMA were more likely to be granted a marketing authorization.

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Obama administration releases National Action Plan to combat antibiotic-resistant bacteria

Thursday, April 2, 2015

The White House has released a comprehensive plan that identifies critical actions to be taken by key Federal departments and agencies to combat the rise of antibiotic-resistant bacteria. The National Action Plan for Combating Antibiotic-Resistant Bacteria, which was developed by the interagency Task Force for Combating Antibiotic-Resistant Bacteria in response to Executive Order 13676: Combating Antibiotic-Resistant Bacteria, outlines steps for implementing the plan.

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NIH forms team to chart course for Precision Medicine Initiative research network

Wednesday, April 1, 2015

A newly created team of experts in precision medicine and large clinical research studies will seek public input from the large and diverse stakeholder community interested in the development of the President’s Precision Medicine Initiative and articulate the vision for building the national participant group for the Initiative. They will help define what can be learned from a study of this scale and scope, what issues will need to be addressed and considered as part of the study design and what success would look like five and 10 years out.

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Regulatory compliance an increasing burden on sites

Wednesday, April 1, 2015

As the biopharmaceutical industry strives to reduce its R&D costs and shorten timelines, it must face the fact that to­day’s successful drug development plans often require more clinical studies than they did a dozen years ago.

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Report: Transparency, cooperation help reduce high prices for new medicines

Friday, March 27, 2015

As the number of new medicines introduced in Europe rises, governments are finding it increasingly difficult to afford them, according to a comprehensive study released today by the WHO Regional Office for Europe. The study illustrates the challenges for national health systems, with specific examples, and shows that few countries in the WHO European Region have mechanisms in place to evaluate the cost-effectiveness of new drugs; this hampers the value-assessment and decision-making processes.

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