Ethics/Regulatory

U.K. Prime Minister commissions independent antibiotics review

Wednesday, July 2, 2014 12:48 PM

U.K. Prime Minister David Cameron, along with the U.K. Department of Health, has commissioned a wide reaching independent review, led by economist Jim O’Neill and co-funded and hosted by medical research foundation the Wellcome Trust, to explore the economic issues surrounding antimicrobial resistance. Growing numbers of bacterial and viral infections are resistant to antimicrobial drugs, but no new classes of antibiotics have come on the market for more than 25 years.

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Quest Diagnostics

Massachusetts becomes 7th state to pass law allowing pharmacy substitution of interchangeable biosimilars

Friday, June 27, 2014 12:08 PM

By Ronald Rosenberg
CenterWatch Staff Writer

Massachusetts this week became the seventh state to allow for the substitution at the pharmacy of biosimilars deemed “interchangeable” with branded original drugs—legislation being enacted on a state-by-state basis.

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Patient-initiated Guidance for Industry for Duchenne submitted to FDA

Wednesday, June 25, 2014 01:51 PM

Parent Project Muscular Dystrophy (PPMD) and a broad coalition of stakeholders have submitted the first-ever patient advocacy-initiated draft guidance for a rare disease to the FDA to help accelerate development and review of potential therapies for Duchenne muscular dystrophy.

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ACRP, European Center for Clinical Research Training collaborate

Thursday, June 19, 2014 01:45 PM

The Association of Clinical Research Professionals (ACRP) and the European Center for Clinical Research Training (ECCRT), a SynteractHCR company, have introduced the ECCRT/ACRP STAR Program, a comprehensive and collaborative clinical research training and development program being offered across Europe.

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ESMO welcomes the adoption of the Clinical Trials Regulation by the E.U.

Tuesday, June 17, 2014 11:06 AM

The European Society for Medical Oncology (ESMO) has welcomed the adoption of the Clinical Trials Regulation by the E.U.

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Aspire IRB, Midlands IRB join WIRB-Copernicus Group

Monday, June 16, 2014 11:01 AM

Aspire IRB and Midlands IRB have joined the WIRB-Copernicus Group (WCG), a provider of regulatory and ethical review services for clinical research.

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Latest AAHRPP accreditations include N.Y. State Department of Health

Thursday, June 12, 2014 01:40 PM

The Association for the Accreditation of Human Research Protection Programs has accredited three more organizations, including one of the nation's largest state health departments and India's national comprehensive cancer center. A nonprofit organization, AAHRPP provides accreditation for organizations that conduct or review human research and can demonstrate that their protections exceed the safeguards required by the U.S. government.

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EMA responds to concerns on its publication of clinical trial data policy

Thursday, June 12, 2014 01:36 PM

The EMA Management Board meeting will consider a draft policy on the publication of clinical trial data. The draft policy arises from the agency’s commitment to increase access to clinical trial data and has been shaped by the many comments received during the consultation phase.

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EFPIA calls for universal adherence to European regulatory framework

Wednesday, June 11, 2014 12:51 PM

EFPIA, the European Federation of Pharmaceutical Industries and Associations, is concerned about a decision by the Italian health authority to allow the reimbursement of off-label treatments for economic reasons when on-label alternatives are available. The organization calls on the European Commission to ensure member states adhere to the European regulatory framework and that financial considerations do not take precedence over regulatory decisions. 

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FDA launches openFDA to provide easier access to FDA public health datasets

Monday, June 2, 2014 01:19 PM

The FDA has launched openFDA, a new initiative designed to make it easier for web developers, researchers and the public to access large, important public health datasets collected by the agency.

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CWWeekly

April 20

Christie Clinic, PMG Research's 12th clinical research site, expands its geographic reach north to Illinois

Clinipace acquires Accovion to expand European presence, following an infusion of equity that could lead to more deals

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The CenterWatch Monthly

April

PSI, INC Research, Chiltern best with sites
Strategic outsourcing prioritizing, improving site relationships

Regulatory compliance an increasing burden on sites
Increased staff time, materials, storage eroding site operating profit

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March

Novo Nordisk, Takeda, Servier, Celgene among top sponsors
New gains seen from patient- and site-centric initiatives

Patient reported outcomes take center stage
FDA combining PROs, clinical outcomes in its approval decisions

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