AiCure

Ethics/Regulatory

EMA, Australian regulators strengthen collaboration in orphan medicines

Wednesday, April 9, 2014 12:38 PM

In a meeting at the EMA April 4, the EMA’s executive director, Guido Rasi, and the national manager of the Australian Therapeutic Goods Administration (TGA), John Skerritt, announced the two regulators have agreed to share the full assessment reports related to marketing authorizations of orphan medicines, intended to treat rare diseases.

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Europe approves clinical trial transparency law

Monday, April 7, 2014 12:39 PM

Pharmaceutical companies and academic researchers will have to post the results of all their European clinical trials in a publicly-accessible database, under a draft law already informally agreed with E.U. ministers and passed by Parliament. The law also facilitates cross-border cooperation to make clinical trials larger, more viable and more reliable, which should in turn boost efforts to develop special treatments (e.g. for rare diseases).

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Proposed health IT strategy aims to promote innovation, protect patients, avoid duplication

Friday, April 4, 2014 12:05 PM

HHS has released a draft report that includes a proposed strategy and recommendations for a health information technology (health IT) framework, which promotes product innovation while maintaining appropriate patient protections and avoiding regulatory duplication. The congressionally mandated report was developed in consultation with health IT experts and consumer representatives and proposes to clarify oversight of health IT products based on a product’s function and the potential risk to patients who use it.

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New structure for NIHR Clinical Research Network

Thursday, April 3, 2014 11:06 AM

The National Institute for Health Research (NIHR) Clinical Research Network, which provides more than $471.4 million a year to support the delivery of clinical research studies in the NHS, has reconfigured and will be operating in a new streamlined structure.

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Congress approves one-year renewal diabetes research funding

Wednesday, April 2, 2014 01:51 PM

The U.S. Senate has approved legislation for a one-year extension of the Special Diabetes Program (SDP)—an initiative that accounts for roughly one-third of all federally funded type 1 diabetes (T1D) research in the U.S. The decision comes on the heels of the March 27 approval of the legislation by the U.S. House of Representatives, and will extend SDP funding for the National Institutes of Health (NIH) at the current level of $150 million, as part of the “Protecting Access to Medicare Act of 2014.”

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Health Research Authority business plan approved to streamline research in U.K.

Wednesday, April 2, 2014 01:44 PM

The U.K. Department of Health has approved the Health Research Authority (HRA) funding plans for HRA Assessment and Approval. This funding means the HRA will be able to reduce duplication and bureaucracy by incorporating assessments by NHS staff alongside the independent Research Ethics Committee opinion, which will result in one application, one assessment and one approval for research in the NHS in England.

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NICE seeks views on how it assesses drugs and other technologies for the NHS

Friday, March 28, 2014 03:15 PM

The National Institute for Health and Care Excellence (NICE) has begun a formal consultation on proposed changes to the way it makes recommendations on new medicines and other treatments for use in the NHS. NICE assesses the clinical and cost effectiveness of new technologies to help ensure patients have access to effective treatments and the NHS makes the best use of its resources.

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Chesapeake IRB acquires Goodwyn IRB

Thursday, March 27, 2014 09:39 AM

Chesapeake IRB has completed the acquisition of Goodwyn IRB.

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PHT launches FDA Roadmap App for patient-focused outcome measurement

Wednesday, March 26, 2014 11:44 AM

Launched by PHT, a provider of technologies used to collect patient-driven eData for clinical research, the new FDA Roadmap App is the first mobile app designed to help sponsors navigate the Roadmap to Patient-Focused Outcome Measurement in Clinical Trials, released by the FDA in conjunction with its Clinical Outcome Assessment Qualification Program. The program and roadmap highlight the process by which a sponsor should consider, choose and/or develop a patient-focused outcome measurement strategy in a clinical program.

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European Medicines Agency launches adaptive licensing pilot project

Thursday, March 20, 2014 01:03 PM

The EMA is inviting companies to participate in its adaptive licensing pilot project. Interested companies should submit ongoing medicine development programs for consideration as prospective pilot cases.

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CWWeekly

November 24

Tufts CSDD’s $2.6 billion price tag to develop and bring a new drug to market raises questions, criticisms

Medidata joins GlaxoSmithKline in study to evaluate the impact of wearing mobile devices in clinical trials

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The CenterWatch Monthly

November

Private equity driving dynamic CRO growth
Enables CROs to pursue long-term strategies, while giving the space credibility

Baby boomers poised to reshape clinical trials industry
Millions of tech-savvy consumers already track their health, expect new treatments as they age

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The CenterWatch Monthly

October

CROs driving changes in patient recruitment
Data- and tech-aided enrollment services a competitive advantage

Trials with in-home nurses poised to grow
Higher expense, but may improve recruitment and retention for select trials

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